[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mcrc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mcrc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,67,89,116,138],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100627260","phase-2-folfiri-and-bevacizumab-with-or-without-pelareorep-for-second-line-treatment-of-metastatic-ras-mutated-microsatellite-stable-colorectal-cancer-100627260",false,"NCT07446322","FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer","An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer","Inclusion Criteria:\n\n* Histologically confirmed cancer of the colon or rectum with documented metastasis\n* Measurable disease per RECIST v. 1.1\n* Not candidates for curative surgery or curative radiation\n* Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in the metastatic setting or relapsed within 6 months of completing adjuvant oxaliplatin\n* Considered medically eligible to receive standard of care (SOC) FOLFIRI with bevacizumab\n* Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H\u002Fnon dMMR) tumor status per a standard local testing method\n* Tumor confirmed to harbor a known RAS mutation per a standard local testing method\n* ECOG performance status of 0 or 1\n* Patients must have adequate hematological, renal, and hepatic function\n* Female patients of childbearing potential must have a negative pregnancy test\n* Life expectancy of at least 6 months\n\nExclusion Criteria:\n\n* Undergone systemic chemotherapy, radiotherapy, or surgery, \\\u003C4 weeks before study treatment\n* Ongoing AEs of Grade ≥2 that are related to anti-cancer treatment\n* Prior treatment with irinotecan\n* Symptomatic brain metastases\n* Active autoimmune disease\n* Receiving immunosuppressive or myelosuppressive medications\n* Active, uncontrolled infections\n* Known HIV infection or active hepatitis B or C that requires anti-viral treatment\n* History of another primary cancer within the last 3 years except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ\n* History of allergy or known hypersensitivity to any of the study drugs, study drug classes,\n* Uncontrolled or severe cardiac disease\n* Received any vaccine within 28 days prior to first study treatment","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is an open-label, randomized, multicenter Phase 2 study to assess the efficacy and safety of FOLFIRI + bevacizumab + pelareorep vs. FOLFIRI + bevacizumab in patients with RAS-mutated, MSS mCRC who have progressed after one prior line of oxaliplatin-based therapy.",[26,27,28],"Ras-mutated Metastatic Colorectal Cancer","mCRC","MSS Metastatic Colorectal Cancer","RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":33},"2026-04-30",{"date":37,"type":20},"2030-04-30",{"name":39,"class":40},"Oncolytics Biotech","INDUSTRY",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100634729","phase-1-a-phase-i-multicentre-randomized-double-blind-parallel-controlled-study-of-hlx05-n-vs-erbitux-in-metastatic-colorectal-cancer-100634729","NCT07543471","A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer","A Multicentre, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic, Efficacy, Safety, and Immunogenicity Profiles of HLX05-N vs. ERBITUX® (US\u002FEU-sourced) in Participants With Metastatic Colorectal Cancer","PK similarity","Inclusion Criteria:\n\n* 1\\. Participants must have signed and dated an IRB\u002FIEC approved written informed consent form (ICF) in accordance with regulatory and institutional guidelines, and is willing to comply with all study procedures and rules required by the protocol.\n\n  2\\. Male or female aged 18-75 years (inclusive) when signing the ICF. 3. 18.5 kg\u002Fm2 ≤ Body mass index (BMI) ≤ 30 kg\u002Fm2 and 50kg ≤ Body weight ≤ 85kg. 4. Participants with a KRAS and NRAS wild type and with no BRAF V600E mutation mCRC.\n\n  5\\. Participants have histologically or cytologically documented locally advanced (unresectable) or metastatic colorectal adenocarcinoma originating from the splenic flexure to the rectum (left colon and rectum).\n\n  6\\. Has not previously received first-line systemic anti-tumor therapy (including systemic chemotherapy, molecular targeted therapy, biological therapy, and other investigational drugs) for recurrent or metastatic CRC\n\nExclusion Criteria:\n\n* 1\\. History of illicit drug use or alcohol abuse in the investigator's judgment within 12 months prior to screening.\n\n  2\\. Prior treatment with VEGF pathway-targeted therapy, EGFR pathway-targeted therapy, or signal transduction inhibitors (e.g., tyrosine kinase inhibitors).\n\n  3\\. Received radiotherapy within 6 months prior to randomization, with the exception of palliative radiotherapy for bone lesions completed more than 14 days prior to randomization. Radiotherapy covering more than 30% of the bone marrow area within 28 days prior to randomization is not permitted.\n\n  4\\. Underwent any major surgery within 4 weeks prior to randomization, or has not fully recovered from any surgery (placement of a vascular access device is not considered a major or minor surgery). For this study, a major surgery is defined as a procedure requiring at least a 3-week recovery period before the participant can receive treatment under this protocol.\n\n  5\\. Has had other active malignancies within 5 years prior to randomization. Participants with cured localized tumors, such as basal cell carcinoma in situ of the skin, squamous cell carcinoma in situ of the skin, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast carcinoma in situ, or thyroid carcinoma in situ, may be enrolled.","75 Years",{"count":52,"type":20},387,[54],"PHASE1","This is a multicentre, randomized, double-blind, parallel-controlled Phase 1 clinical study designed to evaluate the pharmacokinetic (PK) similarity, efficacy, safety, and immunogenicity of HLX05-N compared with US-sourced ERBITUX® and EU-sourced ERBITUX® in participants with metastatic colorectal cancer (mCRC) with wild-type KRAS\u002FNRAS and no BRAF V600E mutation.\n\nApproximately 387 participants will be randomized in a 1:1:1 ratio to receive HLX05-N, US-ERBITUX®, or EU-ERBITUX®. Randomization will be stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) and sex (male vs. female).\n\nDuring the treatment period, participants will receive study treatment in combination with mFOLFOX6 chemotherapy. For the first 3 treatment cycles, participants will receive HLX05-N or US-\u002FEU-ERBITUX® plus chemotherapy according to randomized assignment. After completion of the initial 3 cycles, participants originally assigned to the US-ERBITUX® or EU-ERBITUX® arms will switch, in a blinded manner, to HLX05-N 250 mg\u002Fm² administered in combination with chemotherapy on Day 1 of each cycle. Study treatment will continue until investigator-assessed disease progression, death, initiation of new anti-tumor therapy, unacceptable toxicity, withdrawal of informed consent, study termination, or 1 year after randomization, whichever occurs first.\n\nFor participants with disease response or stable disease after 12 cycles of treatment, oxaliplatin may be discontinued, and maintenance therapy with cetuximab in combination with leucovorin and 5-fluorouracil may continue. Participants who continue to benefit from treatment after 1 year following randomization may receive subsequent therapy according to local clinical practice.\n\nPK and anti-drug antibody (ADA) samples will be collected from all participants to assess PK characteristics and immunogenicity. An end-of-treatment visit will be performed within 7 days after treatment discontinuation. Safety follow-up will be conducted 30 days after the last dose, with an additional telephone safety follow-up at 12 weeks after the last dose. Survival follow-up will continue for up to 1 year after randomization.",[27],"NOT_YET_RECRUITING","2026-04-21",{"date":60,"type":33},"2026-04-24",{"date":62,"type":20},"2026-06-30",{"date":64,"type":20},"2028-04-30",{"name":66,"class":40},"Shanghai Henlius Biotech",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100631540","phase-2-a-clinical-study-of-iparomlimab-and-tuvonralimab-combined-with-fruquintinib-and-heterogeneous-radiotherapy-versus-fruquintinib-as-third-line-and-subsequent-line-treatment-for-metastatic-colorectal-cancer-100631540","NCT07502014","A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer","A Randomized, Parallel, Open-Label, Multicenter Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Patients aged 18 to 75 years (inclusive).\n* Histologically or cytologically confirmed stage Ⅳ primary colorectal cancer.\n* No more than 5 oligometastatic lesions, with metastases usually limited to one or a few specific organs (e.g., liver, lung, etc.), and the metastatic lesions are deemed suitable for stereotactic body radiation therapy (SBRT) by the investigator.\n* Failure of at least 2 prior lines of standard therapy (based on fluorouracil, oxaliplatin, irinotecan, bevacizumab, cetuximab).\n\nNote: Adjuvant\u002Fneoadjuvant therapy is permitted. If recurrence occurs during adjuvant\u002Fneoadjuvant therapy or within 6 months after its completion, the adjuvant\u002Fneoadjuvant therapy will be regarded as the first-line therapy for advanced disease.\n\n* At least one extracranial measurable lesion meeting the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Prior radiotherapy is permitted, but it must be more than 4 weeks before study enrollment. In addition, the lesions selected for radiotherapy and evaluable lesions in this study must be untreated with radiotherapy, and the prior radiotherapy must not affect the normal tissue dose of radiotherapy in this study. (Note: If radiotherapy was received before enrollment, detailed radiotherapy-related parameter data must be provided.)\n* If a subject has undergone surgery, he\u002Fshe must have fully recovered from the toxicities and complications of the surgical intervention before the start of treatment, and enrollment will be considered only after the wound is completely healed.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n* Expected survival of ≥12 weeks.\n* Adequate function of major organs (no use of any blood components or cell growth factors within 2 weeks before enrollment), meeting the following requirements:\n\n  1. Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, white blood cell (WBC) count ≥4.0×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin (Hb) ≥90 g\u002FL.\n  2. Hepatic function: Serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN). If serum total bilirubin level \\>1.5×ULN, direct bilirubin level must be ≤ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (up to 5×ULN for patients with liver metastases).\n  3. Renal function: Blood urea nitrogen (BUN) and serum creatinine (Cr) ≤1.5×ULN (with creatinine clearance rate (CCr) ≥50 mL\u002Fmin).\n  4. Cardiac function: Normal cardiac function with left ventricular ejection fraction (LVEF) ≥50%.\n  5. Coagulation function: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.\n* Male or female patients of childbearing potential must voluntarily use effective contraceptive methods during the study and within 6 months after the last study drug administration, such as double barrier contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered of childbearing potential unless they have natural menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnexectomy, ovarian irradiation, etc.).\n\nExclusion Criteria:\n\n* Prior treatment with anti-PD-1\u002FPD-L1, anti-CTLA-4 agents, or other investigational immunotherapeutic agents.\n* Severe autoimmune diseases, including active inflammatory bowel disease (Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.\n* Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonitis.\n* Risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation.\n* History of other malignancies; however, patients with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast may be enrolled.\n* Patients planning to undergo or having previously received organ or allogeneic bone marrow transplantation.\n* Clinically significant moderate to severe ascites requiring therapeutic paracentesis or drainage, or Child-Pugh score \\>2 (except for radiologically detected minimal ascites without clinical symptoms); uncontrolled moderate or large pleural effusion or pericardial effusion.\n* History of gastrointestinal bleeding or definite bleeding tendency within 6 months prior to initiation of study treatment, including: high-risk or severe esophagogastric varices, active local peptic ulcer lesions, persistent positive fecal occult blood test. (Patients with positive baseline fecal occult blood may be retested; if still positive, esophagogastroduodenoscopy (EGD) is required. Patients with EGD evidence of bleeding-risk varices are excluded.)\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment.\n* Known congenital or acquired bleeding disorders (e.g., coagulopathy) or thrombotic tendency such as hemophilia; currently using or having recently used (within 10 days before study treatment) full-dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes. (Prophylactic use of low-dose aspirin or low-molecular-weight heparin is permitted.)\n* Currently using or having recently used (within 10 days before study treatment) aspirin (\\> 325 mg\u002Fday, maximal antiplatelet dose), dipyridamole, ticlopidine, clopidogrel (≥75 mg), or cilostazol.\n* Thrombotic or embolic events within 6 months prior to initiation of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.\n* Active infection, heart failure, myocardial infarction within 6 months, unstable angina, or uncontrolled arrhythmia.\n* Any physical or clinical laboratory abnormality that, in the investigator's opinion, may interfere with study outcomes or increase the risk of treatment complications, or other uncontrolled medical conditions.\n* Patients requiring urgent palliative radiotherapy or emergency surgery (spinal cord compression, cerebral herniation, pathological fracture) as judged by the investigator.\n* Breastfeeding or pregnant female patients.\n* Congenital or acquired immunodeficiency disorders including human immunodeficiency virus (HIV) infection, or history of organ transplantation or allogeneic stem cell transplantation.\n* Patients with psychiatric disorders, substance abuse, or social issues affecting compliance, as determined by the treating physician.\n* Active infection including active tuberculosis is excluded. Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection may be enrolled if disease is stable following antiviral therapy.\n* Administration of live attenuated vaccines within 30 days prior to enrollment. (Note: Injectable seasonal influenza vaccines are mostly inactivated and permitted; intranasal formulations are usually live attenuated and prohibited.)\n* Poorly controlled cardiac symptoms or diseases including:\n\n  1. New York Heart Association (NYHA) Class ≥II cardiac insufficiency or LVEF \\\u003C50% on echocardiography;\n  2. Unstable angina;\n  3. Myocardial infarction within 1 year prior to initiation of study treatment;\n  4. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;\n  5. QTc interval \\>450 ms (males) or \\>470 ms (females) calculated by Fridericia formula. (If QTc is abnormal, three consecutive measurements at 2-minute intervals may be performed and averaged.)\n* Hypertension not adequately controlled by antihypertensive therapy (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, based on average of ≥2 measurements). History of hypertensive crisis or hypertensive encephalopathy.\n* Major vascular disease within 6 months prior to initiation of study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis).\n* Severe, non-healing or dehiscent wound, active ulcer, or untreated fracture.\n* Major surgery (except diagnostic procedures) within 4 weeks prior to initiation of study treatment, or expected major surgery during the study period.\n* Inability to swallow tablets, malabsorption syndrome, or any condition impairing gastrointestinal absorption.\n* History of intestinal obstruction or clinical signs\u002Fsymptoms of gastrointestinal obstruction within 6 months prior to initiation of study treatment, including partial obstruction related to underlying disease requiring parenteral hydration, parenteral nutrition, or tube feeding.\n* Patients presenting with partial obstruction, obstruction syndrome, or signs\u002Fsymptoms of ileus at initial diagnosis may be enrolled if they received definitive (surgical) treatment resulting in resolution of symptoms.\n* Evidence of intra-abdominal free air not explained by recent paracentesis or surgery.\n* Metastatic disease involving major airways or vessels (e.g., complete occlusion of main portal vein or vena cava due to tumor invasion is excluded; main portal vein is defined as the confluence of splenic and superior mesenteric veins and its bifurcation into right and left intrahepatic branches) or large central mediastinal mass (\\\u003C30 mm from carina).\n* History of hepatic encephalopathy.\n* Current interstitial pneumonitis or interstitial lung disease; history of interstitial pneumonitis or lung disease requiring corticosteroid treatment; pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonitis, idiopathic pneumonia, or evidence of active pneumonitis on screening chest CT with severely impaired pulmonary function. (History of radiation pneumonitis in radiation field is permitted.) Active tuberculosis.\n* Active autoimmune disease or history of autoimmune disease with potential recurrence (including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism). Patients with controlled hypothyroidism requiring only hormone replacement may be enrolled. Patients with skin diseases not requiring systemic therapy (vitiligo, psoriasis, alopecia), controlled type 1 diabetes mellitus on insulin, or childhood asthma in complete remission without adult intervention may be enrolled. Asthma requiring medical intervention with bronchodilators is excluded.\n* Use of immunosuppressive agents or systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) for immunosuppressive purposes within 14 days prior to initiation of study treatment.\n* Known severe hypersensitivity to any monoclonal antibody or anti-angiogenic targeted therapy.\n* Seere infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment. (Patients receiving prophylactic antibiotics are eligible.)\n* Patients with any other conditions that, in the investigator's judgment, may affect study outcomes or lead to premature discontinuation, such as alcoholism, drug abuse, other severe comorbidities (including psychiatric disorders), significant laboratory abnormalities, or family\u002Fsocial issues compromising patient safety, will be excluded.",{"count":19,"type":20},[23],"This is a randomized, parallel, open-label, multicenter exploratory clinical study designed to investigate the efficacy and safety of iparomlimab and tuvonralimab in combination with fruquintinib plus heterogeneous radiotherapy, compared with fruquintinib monotherapy, as the third-line and subsequent-line treatment for patients with oligometastatic colorectal cancer.",[78,27],"Metastatic Colorectal Cancer (CRC)","2026-03-24",{"date":81,"type":33},"2026-03-30",{"date":83,"type":20},"2026-05-01",{"date":85,"type":20},"2029-12-31",{"name":87,"class":88},"Huazhong University of Science and Technology","OTHER",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100620295","phase-2-ma-crc-ii-016-shr-1811-100620295","NCT07355764","MA-CRC-II-016 SHR-1811","SHR-1811 Combined With Bevacizumab as Second-line Treatment in Patients Metastatic CRC","Inclusion Criteria:\n\n-Provide a written informed consent form to voluntarily participate in this study.\n\nMale or female subjects aged 18-75 years.\n\n* Patients with histologically or cytologically confirmed recurrent or metastatic colorectal adenocarcinoma that is not amenable to curative resection.\n* Patients who have experienced disease progression following first-line standard therapy with oxaliplatin combined with fluoropyrimidine-based drugs.\n* Patients with disease progression within 12 months after completion of neoadjuvant or adjuvant therapy are eligible for inclusion.\n* Patients who have previously received irinotecan as part of first-line therapy may be included if investigators from the leading center determine through discussion that the patient is likely to benefit from treatment in the control group.\n* HER2 expression status: Includes patients with HER2 overexpression (IHC 3+ \u002F IHC 2+ with FISH positivity) or HER2 low-to-moderate expression (IHC 2+ with FISH negativity or IHC 1+).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.\n* Ability to provide a report documenting RAS\u002FBRAF gene status.\n* Expected survival time of at least 6 months.\n* Presence of radiologically assessed measurable lesions at baseline (per RECIST 1.1 criteria). Measurable lesions should not have received prior local therapy such as radiotherapy. Lesions located within previously irradiated areas may be selected as target lesions if disease progression in these lesions is confirmed.\n* Adequate function of major organs, meeting the following requirements (administration of blood components or cell growth factors for corrective treatment is not allowed within 14 days prior to the first dose of study medication):\n* Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL Serum albumin ≥ 30 g\u002FL Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \\> 60 mL\u002Fmin (calculated by the Cockcroft-Gault formula) Activated Partial Thromboplastin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 × ULN. Patients receiving stable-dose anticoagulant therapy (e.g., low-molecular-weight heparin or warfarin) with INR within the expected therapeutic range for anticoagulants are eligible for screening.\n* For female subjects of childbearing potential:\n\nA negative serum pregnancy test result is required within 3 days prior to the first dose, and the subject must not be breastfeeding.\n\nMust agree to use effective contraceptive measures during the study period and for at least 7 months after the last dose of SHR-A1811, or for at least 6 months after the last dose of other study medications.\n\n-For male subjects whose partners are of childbearing potential: The subject must have undergone surgical sterilization, or agree to use effective contraceptive measures during the study period and for at least 7 months after the last dose of SHR-A1811, or for at least 6 months after the last dose of other study medications.\n\nSperm donation is prohibited during the study period.\n\nExclusion Criteria:\n\n* Toxicities from prior anti-tumor therapies have not resolved to ≤ Grade 1 per the CTCAE v5.0 criteria (except for toxicities deemed to pose no safety risk by the investigator, e.g., alopecia) or to the levels specified in the inclusion\u002Fexclusion criteria.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with a history of treated brain metastases may be enrolled provided that their brain metastases are stable, and they have not received steroid therapy for brain metastases for at least 28 days prior to study initiation. This exception does not apply to carcinomatous meningitis, as patients with carcinomatous meningitis are excluded regardless of clinical stability.\n* Known microsatellite instability-high (MSI-H) status confirmed by genetic testing or deficient mismatch repair (dMMR) status confirmed by immunohistochemistry.\n* A history of hypersensitivity to monoclonal antibodies, the formulation components of SHR-A1811, or anti-angiogenic agents.\n* Prior treatment with HER2-targeted antibody-drug conjugates (ADCs).\n* Major surgery, open biopsy, or severe trauma within 28 days prior to the first study drug administration.\n* Patients with any severe and\u002For uncontrolled diseases, including:\n\nPatients with inadequately controlled hypertension; Myocardial ischemia or myocardial infarction of Grade ≥1, cardiac arrhythmias (including QT interval ≥ 480 ms), or cardiac insufficiency of Grade ≥1; Active or uncontrolled severe infections; Hepatic diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 10⁴ copies\u002FmL or 2000 IU\u002FmL) or active hepatitis C (positive for hepatitis C antibody with HCV-RNA level above the lower limit of quantification of the assay); Subjects with urine protein ≥ ++ on routine urinalysis and confirmed 24-hour urine protein quantification \\> 1.0 g.\n\n* Clinically significant bleeding symptoms or confirmed bleeding diathesis (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis) within 3 months prior to the first study drug administration.\n* Arterial\u002Fvenous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction; deep vein thrombosis; pulmonary embolism) within 6 months prior to the first study drug administration. Subjects with superficial venous thrombosis may be enrolled at the investigator's discretion.\n* Presence of another concurrent progressive malignancy requiring active treatment, with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix that have undergone potential curative treatment.\n* Any other factors judged by the investigator that may force the subject to discontinue the study prematurely, including severe concurrent illnesses (including mental illnesses) requiring concomitant treatment, severely abnormal laboratory test results, family or social factors that may affect subject safety or the collection of trial data.",{"count":97,"type":20},80,[23],"A randomized, controlled, multicenter clinical study of SHR-A1811 combined with bevacizumab for the second-line treatment of metastatic colorectal cancer",[27,101,102,103],"HER2","Targeted Therapy","Antibody-drug Conjugates",[105,27,106],"SHR-1811","second-line","2026-01-12",{"date":109,"type":33},"2026-01-21",{"date":111,"type":20},"2025-12-30",{"date":113,"type":20},"2028-01-31",{"name":115,"class":88},"Peking Union Medical College Hospital",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100601905","phase-2-radiotherapy-combined-ql1706-tas-102-and-bevacizumab-in-mcrc-100601905","NCT07116577","Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC","A Single-Arm, Exploratory Study of Palliative Radiotherapy Combined With Iparomlimab and Tuvonralimab, Trifluridine\u002FTipiracil (TAS-102), and Bevacizumab in Later-Line Treatment of Advanced Colorectal Cancer","Inclusion Criteria:\n\n* Aged 18 to 75 years .\n* Histologically confirmed unresectable colorectal adenocarcinoma.\n* Patients must have received at least one prior line of oxaliplatin-, irinotecan-, or 5-FU-based therapy with documented progression or intolerance.\n* Documented KRAS and BRAF mutation status (mutant or wild-type) must be available.\n* Palliative radiotherapy targeting primary or metastatic lesions is planned.\n* At least one measurable lesion per RECIST v1.1 exists.\n* ECOG score of 0-1 and life expectancy ≥12 weeks.\n* Adequate bone marrow, hepatic, and renal function must be demonstrated.\n* Fertile patients commit to using effective contraception during and for 6 months post-treatment.\n\nExclusion Criteria:\n\n* History of Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy deemed contraindications for retreatment.\n* Radiation or systemic anticancer therapy within 14 days prior to first study treatment.\n* Active CNS metastases and\u002For leptomeningeal disease (LMD). Symptomatic interstitial lung disease (ILD), active pneumonitis, uncontrolled infections, or non-healing wounds\u002Ffistulae.\n* Intestinal perforation risks: active diverticulitis, intra-abdominal abscess, GI obstruction, or cancer-related peritoneal carcinomatosis.\n* Uncontrolled or symptomatic serous cavity effusions (pleural, ascites, pericardial).\n* Uncontrolled cardiovascular\u002Fcerebrovascular diseases.\n* Medical\u002Fsocial conditions that may compromise study results or lead to premature termination per investigator judgment.",{"count":124,"type":20},37,[23],"This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine\u002Ftipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.",[27],"2025-08-06",{"date":130,"type":33},"2025-08-11",{"date":132,"type":20},"2025-08-31",{"date":134,"type":20},"2028-12-31",{"name":136,"class":88},"Jinan Central Hospital",1,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":137},"100579827","phase-2-thymalfasin-immunotherapy-study-with-triple-regimen-in-advanced-msspmmr-colorectal-cancer-100579827","NCT06829355","\"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS\u002FpMMR Colorectal Cancer\"","Efficacy and Safety Study of Thymalfasin in Combination with Targeted Immunotherapy (Regorafenib and Tislelizumab) in Patients with Advanced PMMR\u002FMSS Colorectal Cancer Who Failed Standard of Care: a Multicenter, Open-label, Randomized, Controlled Clinical Study","THYMI","Inclusion Criteria:\n\n* Able to sign a written informed consent form (ICF) and able to understand and comply with the requirements of this study Male or female aged 18 to 75 Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma Mismatch repair (MMR) protein expression or microsatellite instability (MSI) testing showing pMMR\u002FMSS ECOG score of 0 or 1 At least one measurable lesion per iRECIST Expected survival of ≥ 3 months Disease progression or intolerance after at least second-line standard systemic therapy\n\nNormal major organ function and hematological parameters (within 14 days prior to randomization):\n\nHematology tests must meet the following criteria:\n\nWBCs≥2.0×10\\^9\u002FL NEUT≥1.5×10\\^9\u002FL Hb≥90g\u002FL (9.0g\u002FdL); PLT ≥100×10\\^9\u002FL;\n\nBiochemistry tests must meet the following criteria:\n\nTBIL ≤ 1.5 × upper limit of normal (ULN); Without liver metastases, ALT or AST ≤ 3.0 ULN; with liver metastases, ALT or AST ≤ 5 ULN; Serum albumin level ≥ 30 g\u002FL Serum Cr ≤ 1.5 ULN, with an endogenous creatinine clearance (CrCl) \\> 40 mL\u002Fmin (using Cockcroft-Gault formula) For females: CrCl =((140-Age）×Weight（kg）× 0.85)\u002F(72 × Cr (mg\u002FdL)) For males: CrCl =((140-Age）×Weight（kg）× 1.00)\u002F(72 × Cr (mg\u002FdL)) Urine protein \\\u003C 2+; if urine protein ≥ 2+, 24-hour urine protein must be \\\u003C 1 g Prothrombin time or activated partial thromboplastin time and international normalized ratio ≤ 1.5 × ULN Able to swallow and absorb oral medication Females of childbearing potential must use appropriate contraceptive methods during the study and for 6 months after the last dose of the study drug. For males, they should be surgically sterilized or agree to use appropriate contraceptive methods during the study and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* 1\\. Previous treatment with Regorafenib, PD-1, PD-L1, or CTLA-4 inhibitors, or any form of immunotherapy; 2. Treatment with related drugs or medical technology affecting immunity within 6 months prior to the first dose of the study drug (including but not limited to: thymopentin, interferon, tumor vaccines, CAR-T therapy, etc.); 3. Receiving any study drug, radiotherapy, or major surgery within 28 days prior to the first dose of the study drug; 4. Receiving any anti-tumor treatment (chemotherapy, targeted therapy, etc.) within 3 weeks prior to the first dose of the study drug; 5. Presence of symptomatic central nervous system (CNS) metastases or CNS metastases requiring local CNS-directed therapy (such as radiotherapy or surgery). Exceptions include those previously treated and stable for ≥ 2 months and who have stopped systemic treatment for more than 4 weeks prior to the first dose of the study drug; 6. Known allergy or intolerance to any of the study drugs or their components; 7. Pregnant or lactating females; 8. History of other malignant tumors within the past 5 years (excluding carcinoma in situ or basal cell or squamous cell skin cancer; subjects with other malignant tumors who have been cured for at least 5 years are eligible); 9. Symptomatic congestive heart failure (NYHA Class II-IV), symptomatic or uncontrolled arrhythmias; 10. Poorly controlled hypertension, defined as systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite best medical treatment; 11. Unstable angina (angina symptoms at rest), new onset angina (within the past 3 months), or myocardial infarction within 6 months prior to the first dose of the study drug; 12. Major thrombotic or bleeding events within 6 months prior to randomization (including hemoptysis, gastrointestinal bleeding, hematemesis, central nervous system (CNS) bleeding, severe epistaxis or vaginal bleeding, cerebral infarction, transient ischemic attack, or uncontrolled coronary heart disease). Or requiring lifelong oral anticoagulant therapy; 13. With active, known, or suspected autoimmune diseases; 14. Receiving immunosuppressive agents within 4 weeks prior to the first dose of the study drug, excluding topical glucocorticoids or physiological doses of systemic glucocorticoids administered by nasal, inhalation, or other routes (i.e., no more than 10 mg prednisolone per day or equivalent dosage of other glucocorticoids); 15. Diagnosed with immunodeficiency or on chronic systemic steroid therapy (at a dose in excess of 10 mg prednisone equivalent per day) or any other form of immunosuppressive therapy; 16. History of interstitial lung disease; 17. Active tuberculosis requiring anti-tuberculosis treatment or treatment for tuberculosis within 1 year prior to the first dose of the study drug; 18. Acute or chronic active hepatitis B or hepatitis C; 19. Known history of human immunodeficiency virus (HIV) or syphilis infection; 20. Other active or severe infections requiring systemic antibacterial, antifungal, or antiviral treatment within 4 weeks prior to the first dose of the study drug; 21. Unresolved clinical toxicity ≥ Grade 2 (NCI-CTCAE, v5.0) due to prior anti-tumor treatment, excluding alopecia or non-clinically significant laboratory abnormalities; 22. Intestinal obstruction, gastrointestinal perforation, Crohn's disease, ulcerative colitis, abdominal abscess, chronic diarrhea, or fistula disease within 6 months prior to enrollment; 23. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe cirrhosis; 24. Vaccination with live vaccines within 30 days prior to planned initiation of the study drug (seasonal influenza vaccines without live virus are permitted); 25. History of alcohol abuse or drug abuse; 26. Other acute or chronic diseases, psychiatric disorders, or laboratory abnormalities that the investigator believes would make the use of the study drug unfavorable or affect the interpretation of AEs, or, in the investigator's judgment, would result in inadequate compliance during the study period.",{"count":147,"type":20},52,[23],"This is a multicenter, open-label, prospective, randomized controlled Phase II clinical study. All eligible subjects will be randomly assigned in a 1:1 ratio to either the triple therapy group or the double therapy group.\n\nTriple therapy group: Subjects will receive Thymalfasin in combination with Regorafenib and Tislelizumab until iCPD is achieved per iRECIST (progressive disease (PD) per iRECIST), or until an intolerable toxicity occurs; Double therapy group: Subjects will receive Regorafenib and Tislelizumab until iCPD is achieved per iRECIST (PD per iRECIST), or until an intolerable toxicity occurs.",[151],"MCRC",[153,154,155,27,156,157,158],"Thymalfasin","Regorafenib","Tislelizumab","Combination","Immunotherapy","RCT","2025-02-11",{"date":161,"type":33},"2025-02-17",{"date":159,"type":20},{"date":164,"type":20},"2027-12-31",{"name":166,"class":88},"Beijing Friendship Hospital"]