[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-cancer-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-cancer-recurrent":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,67,89,118,149,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100630919","hpv-after-chemoradiotherapy-100630919",false,"NCT07493928","HPV After chemoRadioTherapy","Implementation of HPV Testing in Patients After Radiotherapy for Cervical Cancer","HART","Inclusion Criteria:\n\n* Patient indicated for primary RT for cervical cancer\n* FIGO stage IB - IVA\n* Signed informed consent\n* Age ≥ 18 years\n* Administration of RT with curative intent\n\nExclusion Criteria:\n\n* Clinical stage FIGO IA\n* Clinical stage FIGO IVB\n* History of radiotherapy in the pelvis\n* Hysterectomy performed before the start of radiotherapy (adjuvant RT)\n* History of HPV-associated malignancy in personal history\n* HIV or other significant immunodeficiency","FEMALE","18 Years",{"count":20,"type":21},120,"ESTIMATED","OBSERVATIONAL","The HART (HPV After chemoRadiotherapy) study is a prospective multicenter observational trial designed to evaluate the clinical utility of HPV testing in the follow-up of patients treated with definitive chemoradiotherapy (CRT) for cervical cancer. Current surveillance after CRT relies mainly on clinical examination and imaging, while the role of HPV-based molecular monitoring remains insufficiently defined. The study plans to enroll 120 patients with FIGO stage IB-IVA cervical cancer treated with primary radiotherapy with curative intent. HPV detection will be performed using two complementary approaches: PCR-based detection of HPV DNA from a cervical swab and analysis of circulating HPV tumor DNA (ctDNA) in peripheral blood. Samples will be collected before treatment and during follow-up at 3, 12, and 24 months after completion of CRT. The primary objective is to determine the sensitivity of these methods for detecting disease recurrence during a two-year follow-up period. Secondary objectives include evaluation of HPV clearance after treatment, comparison of HPV genotypes before and after therapy in cases of persistence, and comparison of the diagnostic performance of cervical HPV testing and ctDNA detection. The study aims to generate evidence supporting the integration of HPV-based molecular monitoring into routine follow-up, potentially enabling earlier detection of recurrence and more individualized surveillance strategies for patients after CRT for cervical cancer.",[25,26,27,28],"Cervical Cancer Recurrent","Radiotherapy","Cell Free DNA","HPV",[30,31,32],"cervical cancer","cfDNA","radiotherapy","RECRUITING","2026-03-20",{"date":36,"type":37},"2026-03-25","ACTUAL",{"date":39,"type":37},"2026-02-01",{"date":41,"type":21},"2030-02-01",{"name":43,"class":44},"General University Hospital, Prague","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100613419","a-non-interventional-registration-study-of-monotherapy-or-combination-regimens-based-on-camrelizumab-or-famitinib-for-the-treatment-of-cervical-cancer-100613419","NCT07266350","A Non-interventional Registration Study of Monotherapy or Combination Regimens Based on Camrelizumab or Famitinib for the Treatment of Cervical Cancer","Inclusion Criteria:\n\n1. Age ≥18 years old;\n2. Sign the informed consent form and voluntarily join this study;\n3. Patients with cervical cancer diagnosed by histopathology;\n4. Receive treatment with monotherapy or combination regimens based on camrelizumab or famitinib;\n5. It is necessary to agree to take effective contraceptive measures and avoid egg donation from the time of signing the informed consent form until 2 months after the last administration of camrelizumab, 3 months after the last administration of famitinib, or within the contraceptive period specified in the instructions of the last administration of other study drugs (whichever is longer).\n\nIf a patient has had menstruation but has not yet reached postmenopausal status (with no menstruation for a continuous period of ≥12 months and no other causes found except menopause), and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation or bilateral oophorectomy), the patient is considered to have fertility.\n\nExclusion Criteria:\n\n1. There is already evidence indicating that the patient is a pregnant or lactating woman.\n2. Currently participating in any research involving intervention measures outside of regular clinical practice;\n3. The researcher determines other circumstances that are not suitable for inclusion in the study.",{"count":53,"type":21},1300,"This trial is a national multicenter, open-label, non-interventional study to observe and evaluate the safety and efficacy of monotherapy or combination regimens based on camrelizumab or famitinib in patients with cervical cancer.\n\nThis study included patients with cervical cancer who used monotherapy or combination regimens based on camrelizumab or famitinib. The administration regimens include but are not limited to camrelizumab monotherapy, camrelizumab in combination with mitinib, famitinib monotherapy, camrelizumab in combination with other treatment regimens selected by the investigator, camrelizumab in combination with mitinib and other treatment regimens selected by the investigator, and famitinib in combination with other treatment regimens selected by the investigator.\n\nIt is planned to include cervical cancer patients who have decided to be treated with monotherapy or combination regimens based on camrelizumab or famitinib before enrollment, with an estimated 1,300 cases.\n\nAccording to the treatment plan received by the patients, after enrollment, they can be respectively placed in one of the following six cohorts:\n\nQueue 1: Only receiving camrelizumab monotherapy\n\nQueue 2: Only receiving famitinib monotherapy\n\nQueue 3: Only combination therapy of camrelizumab and famitinib was received\n\nQueue 4: Receiving camrelizumab in combination with other treatment regimens\n\nQueue 5: Receiving famitinib in combination with other treatment regimens\n\nQueue 6: Receiving camrelizumab and famitinib in combination with other treatment regimens\n\nData from the baseline period, treatment period and follow-up period were collected respectively according to the cohort category (prospective or retrospective) of the enrolled patients.",[56,25],"Cervical Cancer Metastatic","NOT_YET_RECRUITING","2025-12-04",{"date":60,"type":37},"2025-12-05",{"date":62,"type":21},"2025-12-30",{"date":64,"type":21},"2030-12-30",{"name":66,"class":44},"Qi Zhou",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100603959","phase-2-a-prospective-randomized-parallel-trial-of-famitinib-malate-at-different-doses-combined-with-camrelizumab-for-the-treatment-of-recurrent-and-metastatic-cervical-cancer-100603959","NCT07143292","A Prospective, Randomized, Parallel Trial of Famitinib Malate at Different Doses Combined With Camrelizumab for the Treatment of Recurrent and Metastatic Cervical Cancer","Inclusion Criteria:\n\n1. The subjects voluntarily joined this clinical study and signed the informed consent form, demonstrating good compliance, be able to cooperate with follow-up visits;\n2. Age: 18 to 75 years old (inclusive, calculated from the date of signing the informed consent);\n3. Cervical cancer confirmed by histopathology, including cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;\n4. It cannot be cured by surgery, radiotherapy or chemoradiotherapy;\n5. Those who have received platinum-based systemic therapy for recurrent\u002Fmetastatic cervical cancer; The number of previous systemic treatment lines is ≤2;\n6. Has not received bevacizumab treatment in the past;\n7. It can perform biopsies during the screening period and provide fresh tumor tissues for PD-L1 testing;\n8. According to the RECIST v1.1 standard, the patient must have at least one measurable lesion;\n9. ECOG score: 0-1 point;\n10. Be able to swallow pills normally;\n11. The expected survival period is ≥3 months;\n12. The functions of important organs should meet the standards.\n\nExclusion Criteria:\n\n1. History (within the past 5 years) or concurrent presence of other untreated malignant tumors, except for cured thyroid cancer, basal cell carcinoma, carcinoma in situ, and breast cancer that has been completely resected and has not recurred for more than 3 years;\n2. Individuals who have previously received famitinib or are allergic to other monoclonal antibodies;\n3. Individuals with any active, known autoimmune diseases;\n4. Participants who have received systemic treatment with corticosteroids (prednisone or other equivalent hormones at a dose \\>10 mg\u002Fday) or other immunosuppressive agents within the past 4 weeks. In the absence of active autoimmune disease, inhaled or topical corticosteroids, as well as adrenal hormone replacement therapy at a dose ≤10 mg\u002Fday of prednisone equivalent, are permitted;\n5. Known brain metastases or leptomeningeal metastases (excluding cases with brain metastases that have been stable for ≥4 weeks following radiotherapy or surgery);\n6. Imaging studies at screening showing tumor invasion of the bladder or rectum, with an assessed risk of perforation by the investigator;\n7. Spontaneous vaginal bleeding \\>30 ml\u002Fday within 2 weeks prior to randomization, or visible tumors in the vagina, with a risk of bleeding as assessed by the investigator;\n8. Clinical symptoms of ascites or pleural effusion requiring drainage, or drainage of pleural or abdominal fluid within 2 weeks prior to randomization; excluding cases with imaging showing minimal ascites or pleural effusion without clinical symptoms;\n9. History or current presence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pulmonary inflammation (only radiologically demonstrated, those not requiring steroid treatment may be enrolled), drug-induced pneumonia, or active pneumonia during the screening period that the investigator determines precludes enrollment;\n10. Uncontrolled cardiac symptoms or conditions, such as: (1) NYHA Class 2 or higher heart failure; (2) unstable angina; (3) acute myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n11. Hypertension that is uncontrolled despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);\n12. Urinalysis indicating urine protein ≥2+, or quantitative urine protein testing confirming 24-hour urine protein quantification ≥1.0 g;\n13. Currently receiving thrombolytic\u002Fanticoagulant therapy, with prophylactic use of low-dose aspirin (≤100 mg\u002Fday) or low-molecular-weight heparin (≤40 mg\u002Fday);\n14. Patients who experienced any severe bleeding event of grade 2 or higher according to the CTCAE v5.0 criteria within 4 weeks prior to randomization;\n15. Patients with imaging evidence of tumor invasion into major vessels or those deemed by the investigator to have a high likelihood of tumor invasion into major vessels during treatment, potentially leading to life-threatening hemorrhage;\n16. Patients who have experienced intestinal obstruction or required parenteral nutrition within 1 month prior to randomization;\n17. Patients who have experienced arterial or venous thromboembolic events within 6 months prior to randomization, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, excluding lower extremity intermuscular venous thrombosis that, after assessment, does not require anticoagulant therapy, or thrombosis caused by catheter placement that has resolved and does not require medication;\n18. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, etc.);\n19. Patients with radiation enteritis accompanied by bleeding symptoms, or those judged by the investigator to have a risk of risk of gastrointestinal perforation or bleeding;\n20. Patients who have undergone prior radiotherapy, chemotherapy, or tumor surgery, with less than 4 weeks elapsed from the completion of treatment (last dose) to randomization (for patients with bone metastasis, palliative radiotherapy to an area \\\u003C5% of the bone marrow region may be permitted up to 2 weeks prior to randomization); or patients who have taken oral molecularly targeted drugs within 5 drug half-lives prior to randomization; or adverse reactions (excluding alopecia) that have not recovered to ≤ CTCAE v5.0 Grade 1;\n21. Subjects with active infections, or unexplained fever ≥ 38.5°C within 7 days prior to randomization, or those who have used antibiotics within 7 days prior to randomization;\n22. Subjects with congenital or acquired immune deficiencies (e.g., HIV-infected individuals); or active hepatitis (HBV reference: HBsAg positive and HBV DNA ≥ 500 IU\u002FmL or 1000 copies\u002FmL; for hepatitis C: HCV antibody positive and HCV RNA \\> upper limit of normal);\n23. Received a live vaccine within the previous 4 weeks or may receive one during the study period;\n24. The investigator determines that the subject has other factors that may lead to the study being terminated prematurely, such as severe concomitant diseases (e.g., severe diabetes, spinal cord compression, superior vena cava syndrome, mental illness), severe laboratory abnormalities, or family or social factors that may affect the subject's safety or the collection of data and samples;\n25. Severe non-healing wounds, ulcers, or fractures, or abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to randomization.","75 Years",{"count":20,"type":21},"INTERVENTIONAL",[77],"PHASE2","This study is a prospective, randomized, parallel investigation aimed at evaluating different doses of famitinib malate (20mg, 15mg, or 10mg, once daily, respectively) by analyzing the pharmacokinetics, efficacy, safety, and tolerability of famitinib malate combined with camrelizumab at different doses. The feasibility of continuously oral administration combined with camrelizumab in reducing the incidence of adverse events (especially grade ≥3 adverse events) in patients by dose reduction while maintaining comparable efficacy.",[56,25],"2025-11-16",{"date":82,"type":37},"2025-11-18",{"date":84,"type":21},"2025-11-30",{"date":86,"type":21},"2028-06-30",{"name":88,"class":44},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":75,"phases":98,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":4},"100603797","phase-2-ql1706-in-patients-with-recurrent-and-metastatic-cervical-cancer-resistant-to-prior-pd-1pd-l1-antibody-therapy-100603797","NCT07141186","QL1706 in Patients With Recurrent and Metastatic Cervical Cancer Resistant to Prior PD-1\u002FPD-L1 Antibody Therapy","A Prospective, Single-Arm, Phase II Trial of QL1706 in Patients With Recurrent and\u002For Metastatic Cervical Cancer Who Had Developed Resistance to Prior PD-1\u002FPD-L1 Antibody Therapy","Inclusion Criteria:\n\n1. Patients with recurrent\u002Fmetastatic cervical cancer who previously experienced failure of PD-1 blockade therapy;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n3. Life expectancy ≥3 months;\n4. At least one measurable lesion per RECIST v1.1:\n\n   Non-lymph node lesion: Longest diameter ≥10 mm Lymph node lesion: Short-axis diameter ≥15 mm Note: Previously irradiated lesions must be outside radiation fields or demonstrate progression post-radiation.\n5. Adequate organ function within 14 days prior to treatment:\n\n   1. Absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL\n   2. Hemoglobin ≥60 g\u002FL\n   3. Platelet count ≥50×10⁹\u002FL\n   4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN (≤5×ULN for hepatic metastasis)\n   5. Serum creatinine ≤2×ULN\n6. Reproductive requirements:\n\n   1. Non-childbearing potential (surgically sterilized or postmenopausal) OR\n   2. Women of childbearing potential:\n\n   Negative serum pregnancy test within 7 days prior to enrollment Commitment to use double-barrier contraception throughout the study and for 180 days post-treatment\n7. Ability to comply with scheduled visits, treatment plans, and laboratory tests;\n8. Voluntarily signed written informed consent.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-PD-1\u002FCTLA-4 bispecific antibodies;\n2. Active autoimmune disease requiring systemic control with corticosteroids (≥10 mg\u002Fday prednisone equivalent) or immunosuppressants within 14 days prior to enrollment;\n3. Clinically significant cardiovascular\u002Fcerebrovascular events within 6 months prior to treatment, including:\n\n   1. Acute myocardial infarction\n   2. Unstable angina\n   3. Cerebrovascular accident\n   4. Symptomatic arterial\u002Fvenous thrombosis or ischemic cardiomyopathy\n   5. Clinically significant ventricular arrhythmias (sustained VT, VF, torsades de pointes)\n   6. NYHA Class III\u002FIV heart failure\n   7. QTcF ≥480 ms or congenital long QT syndrome\n   8. LVEF \\\u003C50% or severe wall motion abnormality per echocardiography\n   9. Uncontrolled hypertension (SBP \\>160 mmHg or DBP \\>100 mmHg)\n   10. Other clinically significant arrhythmias (e.g., third-degree AV block);\n4. Uncontrolled comorbidities potentially affecting protocol compliance:\n\n   * Severe respiratory diseases (ILD, severe asthma)\n   * Active infections:\n\n     * HBV (HBsAg+ AND HBV-DNA \\>500 IU\u002FmL)\n     * HCV (HCV-Ab+ AND HCV-RNA+)\n     * HIV-Ab+\n     * Active TB or systemic infections requiring treatment ≤14 days\n   * GI perforation\u002Ffistula ≤6 months (exceptions: resolved surgically)\n   * Clinically significant bleeding ≤1 month (hematemesis, hemoptysis, etc.)\n   * Active diverticulitis, abdominal abscess, or bowel obstruction;\n5. Other malignancies within 3 years (excluding cured BCC, superficial bladder Ca, DCIS, or papillary thyroid Ca);\n6. Known immunodeficiency disorders;\n7. History of allogeneic hematopoietic stem cell or solid organ transplantation (excluding corneal grafts);\n8. Systemic infections requiring IV antibiotics \\>7 days within 2 weeks prior to treatment;\n9. Administration of live attenuated vaccines within 4 weeks before\u002Fafter treatment;\n10. Pregnancy or lactation;\n11. Investigator-assessed ineligibility;\n12. Concurrent participation in other clinical trials.",{"count":97,"type":21},50,[77],"To explore the efficacy and safety of administrating QL1706 in patients with recurrent and\u002For metastatic cervical cancer who had developed resistance to prior PD-1\u002FPD-L1 antibody therapies.",[101,56,25,102,103],"Cervical Cancer","Cervical Adenocarcinoma","Cervical Cancer Squamous Cell",[30,105,106,107,108],"immunotherapy","PD-1\u002FCTLA-4 bispecific antibody","QL1706","PD-1 resistant","2025-08-25",{"date":111,"type":37},"2025-08-26",{"date":113,"type":21},"2025-10-01",{"date":115,"type":21},"2030-10-01",{"name":117,"class":44},"Tianjin Medical University Cancer Institute and Hospital",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":128,"studyType":22,"phases":4,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100576119","a-study-to-explore-personalized-treatment-for-patients-with-recurrent-gynecological-malignancies-based-on-mtb-100576119","NCT06781151","A Study to Explore Personalized Treatment for Patients With Recurrent Gynecological Malignancies Based on MTB","A Real-world Study to Explore Personalized Treatment for Patients With Recurrent Gynecological Malignancies Based on Molecular Profiling and Multidisciplinary Team Consultation","RWS-MTB","Inclusion Criteria:\n\n* Patients with recurrent ovarian, cervical, or endometrial cancer referred for multidisciplinary consultation by a gynecological oncologist;\n* Presence of at least one evaluable lesion;\n* Willingness to participate in multidisciplinary consultation;\n* Age 18 years or older;\n* Sufficient tumor tissue for next-generation sequencing (NGS) with a tumor content greater than 32%;\n* Informed consent provided by the participant, indicating understanding of the study procedures and willingness to participate.\n\nExclusion Criteria:\n\n* Patients with concurrent malignancies;\n* Pregnant patients.",{"count":127,"type":21},200,"2 Years","This is a non-interventional, real-world study divided into two parts: a retrospective study and a prospective study.\n\nThe main question it aims to answer is:\n\nWill genomic sequencing and molecular tumor boards lead to clinical responses in patients with recurrent ovarian, cervical, or endometrial cancer? The retrospective arm will analyze data from patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) who underwent multidisciplinary consultations at our institution from January 2022 onward. Data collected will include tumor tissue genomic sequencing results, medical histories, multidisciplinary consultation recommendations, and subsequent treatment courses. This analysis will examine the implementation and clinical efficacy of personalized targeted therapies guided by molecular tumor profiling and multidisciplinary consultation.\n\nThe prospective arm will enroll 200 patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) referred for multidisciplinary consultation. Tumor tissue and blood samples will undergo next-generation sequencing (NGS) to determine molecular tumor profiles. A multidisciplinary expert panel will formulate individualized treatment strategies based on these profiles, patient clinical data, and treatment history. Attending physicians will determine the final treatment plan, integrating multidisciplinary recommendations with patient preferences, comorbidity considerations, drug toxicity assessments, insurance coverage for off-label medications, and the availability of investigational drug trials. This arm aims to observe and evaluate the clinical efficacy of personalized treatment plans developed through molecular tumor profiling and multidisciplinary consultation.",[131,132,25],"Ovarian Cancer Recurrent","Endometrial Cancer Recurrent",[134,135,136,137,138],"genomic sequencing","molecular tumor boards","recurrent ovarian cancer","recurrent endometrial cancer","recurrent cervical cancer","2025-08-20",{"date":141,"type":37},"2025-08-27",{"date":143,"type":37},"2024-04-24",{"date":145,"type":21},"2027-06-18",{"name":147,"class":44},"Sun Yat-sen University",2,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":156,"targetDuration":4,"studyType":75,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":45},"100551050","phase-2-efficacy-and-safety-of-ak104-combined-with-chemotherapy-and-recombinant-human-adenovirus-5-injection-in-cervical-cancer-100551050","NCT06455046","Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Injection in Cervical Cancer","Efficacy and Safety of AK104 Combined With Pemetrexed, Carboplatin and Recombinant Human Adenovirus 5 Injection in Advanced Recurrent Cervical Cancer: a Multicenter, Single-arm, Prospective Phase II Clinical Study","Inclusion Criteria:\n\n\\- 1）Enrollees in this study will be voluntary participants who sign a written informed consent form and are capable of adhering to scheduled visits and related procedures.2) Ages between 18 and 75 years old.3) Histologically or cytologically confirmed cases of persistent, recurrent, or metastatic cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Note: A pathological report is necessary for confirmation of the original primary tumor histology.4) Must have experienced failure with at least one standard systemic treatment and documented disease progression: Failure is defined as progression or recurrence within six months after at least one cycle of standard systemic treatment. Patients who have developed immune acquired resistance may also be included if they experienced PD after achieving CR or PR with anti-PD-1\u002FPD-L1 antibody treatment, or PD after experiencing SD≥6 months with anti-PD-1\u002FPD-L1 antibody treatment.\n\n5\\) Not suitable for local treatments such as unresectable surgery and\u002For definitive concurrent radiotherapy and chemotherapy.6) The interval between the end of previous systemic treatment and the first dose of the study drug must be ≥2 weeks. Additionally, any treatment-related adverse events must have recovered to a grade ≤1 according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 (excluding hair loss and fatigue).7) At least one measurable target lesion must be present according to RECIST V1.1 criteria.8）At least one lesion that can receive local injection therapy using recombinant human adenovirus type 5 should also meet RECIST V1.1 criteria as a measurable lesion.9) ECOG PS 0 or 1.10) The anticipated survival time should be ≥12 weeks.11) Female subjects of reproductive age are required to use effective contraception throughout the treatment period and for at least 5 months after their final dose of the investigational drug.12) Participants must consent to providing an adequate amount of tumor tissue samples for PD-L1 expression detection, which may include archived tumor samples such as paraffin blocks or a sufficient number of unstained slides meeting the study's detection requirements. If no archived tumor tissue samples are available, participants agree to undergo biopsy of the tumor lesion.13）With good organ and hematopoietic function.\n\nExclusion Criteria:\n\n\\- 1) Diagnosed with other malignancies within the 5 years preceding initial dosing, excluding surgically cured basal cell carcinoma or squamous cell carcinoma of the skin, in situ carcinoma that has been surgically resected, and\u002For papillary thyroid carcinoma. Subjects with histologically confirmed small cell (neuroendocrine) cervical cancer, cervical sarcoma, and gastric-type cervical adenocarcinoma.2) Infection at the injection site.3) Presence of ascites, pleural effusion, or pericardial effusion accompanied by clinical symptoms or necessitating drainage. Subjects without clinical symptoms or requiring drainage who have ceased drainage for a minimum of 3 days and show no significant increase in fluid accumulation may be included.4) Individuals scheduled for or having undergone organ or bone marrow transplantation previously.5) Acute or chronic active hepatitis B or C infection with HBV DNA \\>200IU\u002Fml or 103 copies\u002Fml; positive anti-HCV antibody and HCV-RNA level above detection limit. Those treated with nucleoside analog antiviral agents resulting in HBV DNA\u002FHCV-RNA levels below specified standards can be included.\n\n6\\) Central nervous system (CNS) metastasis involving meningeal metastasis or symptomatic CNS metastasis. Asymptomatic brain metastases patients showing stable symptoms after treatment for at least 2 weeks may participate if they meet specific criteria: measurable lesions outside the CNS; absence of meningeal\u002Fmidbrain\u002Fpons\u002Fcerebellum\u002Fmedulla oblongata\u002Fspinal cord metastases; no history of intracranial hemorrhage; cessation of hormone therapy 14 days before first dose.7）Any life-threatening bleeding event within the past three months including need for blood transfusion，surgery，local treatment，or ongoing medication therapy.8）Arterial thrombosis，embolism，or ischemia within six months prior to enrollment including myocardial infarction，unstable angina pectoris ，cerebrovascular accident etc。A history of deep vein thrombosis（DVT）or any other serious thromboembolic events within three months prior to enrollment are not considered \"serious\" thromboembolic events.9）Hepatic vein thrombosis involving both hepatic portal trunk \\& left\u002Fright branches；hepatic portal trunk \\& mesenteric superior\u002Finferior veins；superior vena cava thrombosis\u002Fsuperior vena cava syndrome.10）Tumor invasion into important surrounding organs\u002Fblood vessels such as great mediastinal vessels\u002Fsuperior vena cava\u002Finferior vena cava\u002Fabdominal aorta\u002Filiac vessels\u002Ftrachea\u002Fesophagus；risk of tracheoesophageal fistula \u002Fmediastinal pleural fistula development.11）Uncontrollable hypertension defined as systolic blood pressure ≥150mmHg\u002Fdiastolic blood pressure ≥100mmHg\u002Fhistory hypertension crisis\u002Fhypertensive encephalopathy.12）Symptomatic congestive heart failure(NYHA class II-IV)\u002Fsymptomatic\u002Fpoorly controlled arrhythmias\u002Fprolonged QT interval(QTcF\\>470ms).13）Severe bleeding tendency\u002Fcoagulation dysfunction\u002Fcurrently receiving thrombolytic therapy.14）History gastrointestinal perforation\u002Ffistula last six months\u002Fbowel obstruction(including incomplete bowel obstruction requiring parenteral nutrition)\u002Finflammatory bowel disease\u002Fextensive bowel resection(Crohn's disease\u002Fulcerative colitis\u002Fchronic diarrhea).15 ) History interstitial pneumonitis\u002Fdrug-induced pneumonitis\u002Fradiation pneumonitis\u002Fidopathic pneumonitis \u002Factive pneumonitis.16 ) Active tuberculosis(TB)，currently receiving anti-TB therapy\u002For received study drug previous year.17 ) Human immunodeficiency virus(HIV)(HIV1\u002FHIV2 antibody positive), known active syphilis infection.18 ) Active\u002Fseverely uncontrolled infections hospitalization severe infections(infections\u002Fsepsis\u002Fsevere pneumonia complications etc.)within four weeks prior to first dose.19 ) Oral\u002Fintravenous therapeutic antibiotics one week before starting study treatment.20 ) Systemic autoimmune diseases\u002Frequiring systemic treatment\u002Ftwo-year history(white vitiligo、psoriasis、alopecia、Graves' disease not requiring systemic treatment\u002Fhypothyroidism only needing thyroid hormone replacement\u002Ftype1 diabetes only needing insulin replacement). Known primary immunodeficiency history Only patients with positive autoimmune antibodies need confirmation by investigator presence autoimmune disease.21 ) Immunosuppressive drugs use four weeks except nasal inhalant local corticosteroids\u002Fsystemic corticosteroids physiological doses(no more than prednisone equivalent daily doses other cortico steroids temporary use relief breathing difficulties due asthma\u002FCOPD).22 ) Live attenuated vaccine four weeks planned during study period.23 ) System immune stimulant treatments four weeks.24)Major surgery(craniotomy\u002Fthoracotomy\u002Flaparotomy)prior four weeks\u002Funhealed wound ulcer fracture.25)Uncontrolled\u002Fmetabolic disorder\u002Fnon-malignant organ\u002Fsystemic diseases\u002Fcancer-related complications\u002Fhigher medical risk uncertainty survival period evaluation.26) Other acute chronic conditions psychiatric disorders laboratory test abnormalities increasing risk participating study\u002Freceiving study drug interfering interpretation results determined investigator patient eligible participate thisstudy.27) Received oncolytic virus therapy past received anti-CTLA-4 antibodytherapy past.28) Known allergic AK104,pemetrexed,cisplatin,and Recombinant Human Adenovirus 5 Injection components\u002Fsevere allergic reaction monoclonal antibodies past.29) Received investigational drug treatment previousfourweeks starting studytreatment.30) No anticancer therapies received previousfourweeks startingstudyoral chemotherapy(two-week washout oral fluoropyrimidine-based drugs), endocrine targeted therapies(small molecule targeted therapies two-week half-life longer),immunotherapy,tumor embolization Chinese herbal medicine indications.31) Pregnant breastfeeding femalepatients",{"count":157,"type":21},37,[77],"In order to improve the clinical effect and find a new safe and effective treatment model for advanced recurrent cervical cancer, this study explored the efficacy level safety of pemetrexed, carboplatin, recombinant human adenovirus type 5, and AK104 regimen in recurrent and refractory advanced cervical cancer. For some patients with immune-resistant cervical cancer, combination chemotherapy and oncolytic virus therapy can promote the transformation of cold tumors into hot tumors, eliminate and then reverse the suppressor factors of immune resistance, and break the dilemma of immunotherapy drug resistance, which is a new method and strategy under immunotherapy drug resistance.",[25],"2024-06-06",{"date":163,"type":37},"2024-06-12",{"date":165,"type":37},"2023-10-11",{"date":167,"type":21},"2025-10-10",{"name":169,"class":170},"Fujian Cancer Hospital","OTHER_GOV",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":73,"enrollmentInfo":178,"targetDuration":4,"studyType":75,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":45},"100520934","phase-2-rc48-combined-with-tislelizumab-for-second-line-treatment-of-her2-expression-in-recurrent-cervical-cancer-100520934","NCT06063018","RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer","A Single-arm, Single Center, Phase II Study of RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer","Inclusion Criteria:\n\n1. Female subjects aged from 18 to 75 years old；\n2. Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1；\n3. Have a life expectancy of at least 6 months, in the opinion of the investigator；\n4. Histologically or cytologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, or small cell (neuroendocrine) cervical cancer;\n5. Have measurable disease assessable by RECIST v1.1；\n6. Adequate haematological, hepatic and renal functions defined by the protocol； Pathologically diagnosed patients with HER2 expression （defined as: IHC 3+ or IHC 2+ or HC 1+）advanced cervical cancer ；Note：It is also acceptable if the subject has previous test results (confirmed by the investigator)；\n7. Negative blood pregnancy test at Screening for women of childbearing potential；Highly effective contraception for female subjects if the risk of conception exists；\n\nExclusion Criteria:\n\n1. History of malignant tumors other than cervical cancer, except for the following two cases：a. The patient had received a potentially curative treatment and had no evidence of the disease for 5 years；b. Successful resection of skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ, and other carcinoma in situ was received；\n2. Previous malignant disease (other than cervical cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)Previous stem cell allogeneic or parenchymal organ transplants；\n3. Patients who had previously received other anti-tumor systemic therapy (including traditional Chinese medicine with anti-tumor indications) less than 4 weeks before the use of this study, or adverse events caused by previous treatment did not recover to ≤CTCAE grade 1 (except for alopecia and pigmentation)；\n4. Had received a live vaccine within 4 weeks prior to the start of study dosing or planned to receive any vaccine (except for COVID-19 vaccine) during the study period；\n5. Previous or current congenital or acquired immunodeficiency disease；\n6. Previous treatment with other antibody-coupled drugs；\n7. Has not recovered from surgery, such as the presence of unhealed incisions or serious postoperative complications；\n8. The patient had a known or suspected allergy to the experimental drug；\n9. The New York College of Cardiology (NYHA) classiifies heart failure as grade 3 and above；\n10. Severe infections that are active or poorly controlled clinically; Active infections, including: a. HIV (HIV1\u002F2 antibody) positive; b. Active hepatitis B (HBsAg positive or HBV DNA \\> 2000IU\u002Fml and abnormal liver function); c. Active hepatitis C (HCV antibody positive or ≥103 copies \u002Fml of HCV RNA and abnormal liver function); d. active tuberculosis; d. Other uncontrolled active infections (CTCAE V5.0 \\> Grade 2);\n11. Other significant clinical and laboratory abnormalities considered to affect safety assessment, such as uncontrolled diabetes, chronic kidney disease, grade II or above peripheral neuropathy (CTCAE V5.0), thyroid dysfunction, etc.； Other conditions deemed unsuitable for inclusion by the researchers；",{"count":179,"type":21},30,[77],"There is currently no standardized treatment for patients who have undergone first-line standard treatment. In this study, We investigated the efficacy and safty of RC48 combined with Tislelizumab in the second-line treatment of patients with HER2 expression in recurrent cervical cancer.",[25],"2023-09-25",{"date":185,"type":37},"2023-10-02",{"date":187,"type":37},"2023-08-16",{"date":189,"type":21},"2026-08",{"name":191,"class":44},"Peking Union Medical College Hospital"]