Actively Recruiting
Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma
Led by Sir Run Run Shaw Hospital · Updated on 2025-08-06
59
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
1. Primary Objectives (1) To evaluate the safety and tolerability of sacituzumab tirumotecan in combination with pucotenlimab in patients with advanced cholangiocarcinoma; (2) To assess the objective response rate (ORR) of sacituzumab tirumotecan combined with pucotenlimab in patients with unresectable or metastatic cholangiocarcinoma, as evaluated by investigators per RECIST v1.1; 2. Secondary Objectives (1) To evaluate the overall survival (OS) of sacituzumab tirumotecan combined with pucotenlimab in advanced cholangiocarcinoma; (2) To assess progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), and time to response (TTR) in patients treated with sacituzumab tirumotecan combined with pucotenlimab, as determined by investigators based on RECIST v1.1; (3) To further evaluate PFS (as a standalone secondary endpoint); 3. Exploratory Objectives (1) To investigate the correlation between TROP2 expression, systemic immune biomarkers, and treatment efficacy.
CONDITIONS
Official Title
Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed unresectable or metastatic cholangiocarcinoma, including gallbladder, intrahepatic, and extrahepatic types
- For first line treatment cohort: patients who refuse chemotherapy, have failed adjuvant chemotherapy, or have not received systemic therapy
- For second line treatment cohort: patients intolerant to first line chemotherapy or with disease progression after first line chemotherapy
- Positive for TROP2 protein
- Distant metastasis or locally advanced disease not suitable for surgery or radiotherapy and no prior systemic treatment
- Measurable primary tumor lesion according to RECIST 1.1 criteria
- No active autoimmune diseases
- No concurrent malignant tumors
- ECOG performance status 0-1
- Expected survival of at least 3 months
- Adequate organ and bone marrow function without recent blood transfusions or growth factor therapy
- Effective contraception use for patients of reproductive potential during study and for 6 months after
- Willingness to voluntarily join the study and provide informed consent
You will not qualify if you...
- Prior treatment with targeted TROP2 therapies, topoisomerase I inhibitors, immune checkpoint inhibitors, immune cell therapies, or other immune-targeting treatments
- Other malignant tumors within 3 years except certain cured skin or cervical cancers
- Diagnosis of ampullary cancer
- Allergies to sacituzumab tirumotecan or pucotenlimab
- History or current interstitial lung disease or pneumonia requiring steroid treatment
- Active autoimmune diseases requiring systemic treatment within past 2 years
- Need for systemic corticosteroids or immunosuppressants within 10 days before study treatment
- Active pulmonary tuberculosis
- History of allogeneic organ or stem cell transplantation
- Active hepatitis B or C infection
- Positive HIV test or history of AIDS
- Active syphilis infection
- Local or systemic diseases increasing medical risk or affecting survival evaluation
- Severe eye diseases hindering corneal healing
- Inability to comply with study visits and procedures
- Pregnant or lactating women
- Vulnerable populations such as critically ill, mentally ill, or cognitively impaired individuals
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (Qingchun Campus) 3 Qingchun Road East, Shangcheng District, Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
M
Mingyu Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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