Gemcitabine and cisplatin plus PD‑1/PD‑L1 immunotherapy for advanced cholangiocarcinoma
A Phase I/II Study of Anti-PD-1/PD-L1 Antibodies in Combination With Gemcitabine and Cisplatin for Patients With Advanced Cholangiocarcinoma
It will try combining standard gemcitabine-plus-cisplatin chemotherapy with a PD‑1/PD‑L1 immunotherapy for adults with advanced, unresectable or metastatic cholangiocarcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | prednisone, pembrolizumab, durvalumab, envafolimab, tislelizumab, chemotherapy, Immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07291063 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of adults with locally advanced or metastatic cholangiocarcinoma who receive first-line gemcitabine and cisplatin together with a PD‑1/PD‑L1 antibody in routine clinical practice. The study records safety, tolerability, and clinical outcomes such as response and survival while patients receive the combination. Immunotherapy agents may include drugs like pembrolizumab, durvalumab, envafolimab, or tislelizumab alongside standard chemotherapy. The goal is to document real-world effects and side-effect profiles outside of randomized trial settings.
Who should consider this trial
Good fit: Adults (≥18) with histologically or cytologically confirmed locally advanced or metastatic biliary tract cancer (intrahepatic, extrahepatic, or gallbladder) not amenable to curative surgery, ECOG 0–1, adequate organ function, and expected survival of at least 12 weeks are the intended participants.
Not a fit: Patients with active or a history of clinically significant autoimmune disease, poor performance status (ECOG ≥2), inadequate organ function, or those who are candidates for curative surgery are unlikely to benefit from this regimen in this setting.
Why it matters
Potential benefit: If successful, the combination could provide longer survival and better tumor control than chemotherapy alone while clarifying real-world safety and tolerability.
How similar studies have performed: Previous randomized trials such as TOPAZ-1 and KEYNOTE-966 have shown that adding PD‑1/PD‑L1 immunotherapy to gemcitabine–cisplatin improves overall survival, so this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. ≥18 years old, male or female 2. Histologically or cytologically confirmed locally advanced or metastatic biliary tract cancer (including ICC, ECC, or GBC) that is not amenable to curative surgery or local therapies. 3\. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4. Patient has given written informed consent. 5. The function of important organs meets the requirements 6. Expected survival ≥12 weeks 7. Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period. Exclusion Criteria: * 1\. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included); 2. The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount \> 10 mg / day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment; 3. Have clinical symptoms or disease that are not well controlled; 4. Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization; 5. Arterial/venous thrombosis in the first 6 months of randomization 6. According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.#with family or social factors, it will affect the safety of patients. 7. Known hypersensitivity to Gemcitabine, Cisplatin, or platinum-containing compounds; significant hearing impairment (grade ≥2) or peripheral neuropathy (grade ≥2) that contraindicates Cisplatin;
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital Fudan university — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qinghai Ye, PhD
- Email: 24111210117@m.fudan.edu.cn
- Phone: 2164041990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.