Tislelizumab

15

Review clinical trials related to Tislelizumab. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma

Esophageal cancer (EC) ranks among the leading malignant gastrointestinal tumors globally in terms of both incidence and mortality. Cases of EC in China account for over 50% of the global total, with squamous cell carcinoma being the primary pathological type. Locally advanced EC (LAEC), particularly cases where radical surgical resection is not feasible, exhibits high recurrence rates and low 5-year survival rates. However, studies have shown that patients with LAEC who undergo comprehensive treatment followed by surgery experience significantly prolonged survival and improved quality of life compared to those who do not receive surgical intervention. Current conversion treatment regimens under investigation include: chemotherapy alone, chemoradiotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with chemoradiotherapy-each of these approaches has distinct advantages and limitations. Immunochemotherapy has emerged as a current research focus: it not only demonstrates significantly superior efficacy compared to chemotherapy alone but also exhibits lower cumulative toxicity than radiotherapy-combined conversion regimens, resulting in a more favorable overall benefit-risk ratio. As such, it represents the most promising conversion treatment strategy. Retrospective and prospective clinical studies have shown that low-dose radiotherapy targeting the small intestine can enhance the anti-tumor response of immune checkpoint inhibitors (ICIs) in patients with advanced solid tumor, prolong their overall survival, and increase the incidence of the abscopal effect. Further mechanistic investigations have revealed that intestinal low-dose radiotherapy (ILDR) may augment the immune cancerous lethality by modulating the gut microbiota and their metabolic profiles. Based on the findings from these preliminary studies, the current research plans to conduct a prospective phase II single-arm clinical trial to investigate the efficacy and safety of ILDR combined with immunochemotherapy as conversion therapy in patients with borderline resectable or unresectable esophageal squamous cell carcinoma (BR/UR ESCC). This research plans to enroll at least 39 evaluable cases or a total of 43 cases in two seperated stages, focusing on patients with thoracic BR/UR ESCC. Patients will receive a single fraction of ILDR with a mean dose of 1 Gy, concurrently with 3 cycles of albumin-bound paclitaxel (260 mg/m² on day 1), cisplatin (75 mg/m² on day 1), and tislelizumab (200 mg on day 1). The efficacy and safety of the treatment will be evaluated throughout the study.

Participants needed: 43
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Chuangzhen ChenUpdated: Jun 18, 2026Locations: 1
Eligibility criteria

Patients voluntarily enroll in this study, sign an informed consent form, and de... [+17]

Patients with distant metastases other than supraclavicular lymph node metastase... [+17]

Status: Recruiting

Tislelizumab Combined With Anlotinib and Nab-paclitaxel in III Resectable Non-small Cell Lung Cancer : A Prospective, Single-Arm, Phase II Study

This study is a single-arm prospective clinical trial. The primary objective of the study is to explore the efficacy and safety of preoperative neoadjuvant therapy with Tislelizumab combined with Anlotinib and Nab-Paclitaxel in resectable stage III non-small cell lung cancer.Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.

Participants needed: 34
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Qilu Hospital of Shandong UniversityUpdated: Jun 15, 2026Locations: 1
Eligibility criteria

Age 18-75 years old, gender is not limited; [+9]

A history of received treatment for current lung cancer, including radiotherapy... [+16]

Status: Recruiting

A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy

To find out if a combination of fruquintinib and tislelizumab can control CRC in patients who have received treatment for the disease but still have "positive" ctDNA tests for MRD (meaning there is evidence of MRD based on this test).

Participants needed: 20
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: M.D. Anderson Cancer CenterUpdated: Jun 1, 2026Locations: 1
Eligibility criteria

Participants must have histologically or cytologically confirmed microsatellite... [+20]

Has other concomitant active, invasive malignancies that may interfere with ctDN... [+30]

Status: Not yet recruiting

Tislelizumab Plus Chemotherapy and BACE for Unresectable NSCLC

The goal of this phase 2 trial is to evaluate the efficacy and safety of tislelizumab combined with intravenous chemotherapy and bronchial artery chemoembolization (BACE) as conversion therapy for patients with initially unresectable stage IIIA-IIIB non-small cell lung cancer (NSCLC). The main questions it aims to answer are: * What is the 1-year event-free survival (EFS) rate with this treatment? * Can this treatment improve tumor response and the chance of curative-intent resection? * What adverse events occur during treatment? Participants will receive tislelizumab, intravenous chemotherapy, and BACE for up to 4 cycles. Tumor response and resectability will be evaluated by imaging and multidisciplinary team (MDT) assessment every 2 cycles. Participants who become resectable may undergo surgery followed by postoperative treatment per protocol. Participants who remain unresectable after 4 cycles will receive guideline-recommended chemoradiotherapy followed by tislelizumab consolidation. Regular follow-up will be performed for efficacy and safety assessment.

Participants needed: 39
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Sichuan Cancer Hospital and Research InstituteUpdated: May 1, 2026Locations: 1
Eligibility criteria

Age 18 to 80 years [+12]

Prior local therapy for NSCLC, including radiotherapy or interventional therapy [+12]

Status: Not yet recruiting

Prospective, Open-label, Multi-cohort Study of Becotatug Vedotin With Tislelizumab and Chemotherapy in Esophageal Squamous Cell Carcinoma - Phase 2

Esophageal squamous cell carcinoma (ESCC) is a common malignant tumor worldwide, with particularly high incidence in East Asian regions such as China, and is associated with poor patient prognosis. In recent years, immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1 antibodies) combined with chemotherapy have become the standard first-line treatment for advanced ESCC. Multiple randomized controlled trials have confirmed that this combination significantly improves patient survival compared to chemotherapy alone. However, a subset of patients still exhibit poor response or develop resistance to the immunotherapy-chemotherapy regimen, necessitating the exploration of novel combination strategies to further enhance efficacy. The epidermal growth factor receptor (EGFR) is frequently overexpressed in ESCC and is associated with tumor proliferation, metastasis, and poor prognosis, making it an important therapeutic target. Antibody-drug conjugates (ADCs) targeting EGFR achieve precise tumor killing by conjugating an anti-EGFR antibody to a potent cytotoxic payload. Preclinical studies have demonstrated significant antitumor activity of EGFR ADCs in ESCC models. Mechanistically, anti-EGFR therapy and immune checkpoint inhibitor therapy may exert synergistic effects through several avenues: enhancing tumor antigen presentation, remodeling the tumor microenvironment, and modulating PD-L1 expression. Therefore, this triple combination strategy holds promise for overcoming the limitations of monotherapies and providing a new treatment option for patients with ESCC.

Participants needed: 93
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Tianjin Medical University Cancer Institute and HospitalUpdated: Apr 15, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years. [+18]

Prior treatment with any anti-EGFR monoclonal antibody, or with anti-PD-1/PD-L1... [+10]

Status: Recruiting

Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR/MSS Locally Advanced Rectal Cancer

This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).

Participants needed: 50
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Seventh Medical Center of PLA General HospitalUpdated: Mar 10, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years [+21]

History of multiple primary cancers or concomitant malignant tumors other than r... [+11]

Status: Recruiting

Nephron-sparing Treatment of Tislelizumab + Nab-Paclitaxel for Renal Pelvic Cancer

This study is designed as an open-label, single-arm, single-center, phase II clinical trial, aiming to evaluate the efficacy of nephron-sparing treatment combining Tislelizumab and Nab-Paclitaxel for HER-2 expressing renal pelvic cancer (RPC) . Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo evaluation. Patients who achieve all of the following criteria of "well response and tolerance" will receive further maintenance treatment: (1)The patient achieves a complete response (CR) or partial response (PR) according to the RECIST 1.1 criteria, indicating that the tumor is well-controlled. (2) If the patient has residual lesions, it should be confirmed by the clinical physician that these lesions can be eliminated through laser ablation via ureteroscopy. (3)The patient has not experienced any treatment-related adverse events (TRAEs) that warrant discontinuation of therapy during systemic treatment. (4)The patient is willing to undergo further maintenance therapy. If the patient meets all the criteria above, ureteroscopic biopsy should be performed. If residual lesions are detected under the ureteroscope, endoscopic intervention (e.g., laser ablation, cryoablation) should be carried out simultaneously to eliminate these residual lesions. Patients who meet the above criteria will proceed with no less than 2 cycles of maintenance systemic therapy (Tislelizumab + Nab-Paclitaxel). Patients who do not meet the criteria will be excluded from the study and are recommended to undergo salvage radical nephroureterectomy (RNU) as soon as possible. One-year Nephron-Sparing Survival (1 year-NSS): Defined as the absence of surgical indications for nephrectomy due to progression or recurrence of upper urinary tract urothelial carcinoma, distant metastasis caused by the primary upper urinary tract tumor, or death from any cause within 1 year from the initiation of treatment. Treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.

Participants needed: 35
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Tianjin Medical University Second HospitalUpdated: Nov 18, 2025Locations: 1
Eligibility criteria

Males or females aged no less than 18 years old; [+6]

Concurrent primary malignancies in other sites are excluded, except for those wi... [+14]

Status: Recruiting

Real World Study of Platinum Containing Dual Drug Chemotherapy Followed by Large Fractionated Radiotherapy Combined withTislelizumab in Stage IIIB/C-IV Non-small Cell Lung Cancer Patient

In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.

Participants needed: 20
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Zibo Municipal HospitalUpdated: Sep 30, 2025Locations: 1
Eligibility criteria

Age 18-75 years old, gender is not limited; [+3]

Patients with uncontrolled autoimmune diseases; [+6]

Status: Recruiting

Neoadjuvant Tislelizumab + Nab-Paclitaxel Followed by Distal Ureterectomy for Ureteral Cancer

This study is designed as an open-label, single-arm, single-center, phase II clinical trial, aiming to evaluate the efficacy and safety of neoadjuvant Tislelizumab combined with Nab-Paclitaxel followed by distal ureterectomy for patients with non-metastatic ureteral cancer (UTC). Patients enrolled will receive 2-3 cycles of Tislelizumab in combination with Nab-Paclitaxel every 3 weeks and then undergo distal ureterectomy (DU). The assessment of efficacy is based on the histology of specimen from DU, and treatment-related adverse events (TRAEs) will be recorded and evaluated according to CTCAE 5.0.

Participants needed: 35
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Tianjin Medical University Second HospitalUpdated: Aug 15, 2025Locations: 1
Eligibility criteria

Males or females aged no less than 18 years old; [+5]

Concurrent primary malignancies in other sites are excluded, except for those wi... [+14]

Status: Recruiting

Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer

This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of surufatinib and tislelizumab in combination with concurrent chemoradiotherapy, followed by consolidation therapy with tislelizumab plus surufatinib, in patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).

Participants needed: 80
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Sun Yat-sen UniversityUpdated: Jul 25, 2025Locations: 1
Eligibility criteria

A written and dated informed consent form must be obtained prior to the initiati... [+11]

Participation in another clinical study, unless it is an observational (non-inte... [+15]

Status: Recruiting

Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer:A Prospective, Single-Arm, Phase II Study

In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of Tislelizumab combined with platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.

Participants needed: 20
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Zibo Municipal HospitalUpdated: Jul 25, 2025Locations: 1
Eligibility criteria

Age 18-75 years old, gender is not limited; [+3]

Patients with uncontrolled autoimmune diseases; [+7]

Status: Not yet recruiting

Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer

This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Participants needed: 44
Trial details
Phase: Phase 1, Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Sixth Affiliated Hospital, Sun Yat-sen UniversityUpdated: Mar 12, 2025Locations: 1
Eligibility criteria

18-75 years old (including 18 and 75 years old); [+7]

Patients who had received any drug in the study protocol in the last year; [+16]

Status: Recruiting

Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High-risk Recurrence Factors

This is a monocenter, single-arm, open-label study to evaluate the efficacy and safety of Lenvatinib combined with Tislelizumab and TACE applied as neoadjuvant regimen for the patients of CNLC stage IB and IIA hepatocellular carcinoma with high risk of recurrence Primary outcome: Major pathological response (MPR) Secondary outcomes: pathological complete response (pCR), R0 resection rate, objective response rate (ORR), disease control rate (DCR), treatment-related adverse events (TRAE)

Participants needed: 35
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Zhejiang Cancer HospitalUpdated: Feb 11, 2025Locations: 1
Eligibility criteria

Aged 18-75 years old (inclusive); [+8]

Pathologically diagnosed as non-hepatocellular carcinoma; [+14]

Status: Recruiting

XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC

The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy,in MSS/pMMR-type RAS-mutated metastatic colorectal adenocarcinoma. The main questions it aims to answer are efficacy and safety of the regimen of XELOX +Bev +Tislelizumab. The investigators want to transform ras-mutated colorectal cancer into a "hot tumor" through the combination of anti-vascular therapy and chemotherapy, and then achieve better therapeutic effect through the combination with immunotherapy. Participants will receive the regimen of XELOX +Bev +Tislelizumab.

Participants needed: 52
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Cancer Institute and Hospital, Chinese Academy of Medical SciencesUpdated: Aug 1, 2023Locations: 1
Eligibility criteria

Histologically confirmed initially unresectable MSS/pMMR-type RAS-mutant metasta... [+9]

Previously received bevacizumab or anti-CTLA4, anti-PD-1/PD-L1 therapeutic antib... [+22]

Status: Not yet recruiting

Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer

This study is a multi-center, single-arm, open-label phase II clinical trial, aiming to observe and evaluate the perioperative treatment of tislelizumab combined with chemotherapy (CAPOX) in stage II or III colorectal cancer with MSI-H/dMMR Patient efficacy and safety.

Participants needed: 25
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: The First Affiliated Hospital of Zhengzhou UniversityUpdated: May 9, 2023
Eligibility criteria

ECOG: 0~1; [+5]

Have received anti-tumor therapy; [+8]