Gemcitabine and cisplatin plus PD‑1/PD‑L1 immunotherapy for advanced cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongshan Hospital Fudan university
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Qinghai Ye, PhD
• Email: 24111210117@m.fudan.edu.cn
• Phone: 2164041990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SumMET: Targeted radioligand therapy for c-MET–positive solid tumors

  This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.

  Recruiting at 2 sites Phase 1/2 Full-Life Technologies UK Limited · Minneapolis, Minnesota and 1 other locations · NCT07873450

• 68Ga-SorB PET/CT imaging for solid tumors

  This study tests a new PET tracer called 68Ga-SorB to see if it can safely and accurately detect tumors in adults with melanoma, liver, lung, breast, pancreatic, ovarian cancer, or cholangiocarcinoma.

  Recruiting Peking University Third Hospital · Beijing, Beijing Municipality · NCT07760012

• Breath test to help detect gastrointestinal cancers early

  A breath test that looks for signals in exhaled air to see if someone with gut cancer symptoms might have oesophageal, stomach, pancreatic, liver, or colorectal cancer and need urgent testing.

  Recruiting Imperial College London · Maidstone, Kent and 5 other locations · NCT07714538

• Can an imaging tracer help predict if cholangiocarcinoma patients will respond to standard therapy

  This study tests whether an imaging tracer called [18F]FTT used with PET/CT can predict how newly diagnosed cholangiocarcinoma patients will respond to the standard treatment of gemcitabine, cisplatin, and durvalumab.

  Recruiting Phase 2 University of Washington · Seattle, Washington · NCT07673341

• Dual-target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer

  This trial tests a ready-to-use CAR-NK cell therapy that targets HER2 and CEACAM5 in adults with unresectable or metastatic biliary tract cancers after standard therapy to see if it can help control the disease.

  Recruiting Phase 1/2 Beijing Biotech · Shenzhen, Guangdong · NCT07641036

• KRAS G12V cancer patients get TCR1188-ABC cell therapy

  This early-phase trial tests whether TCR1188-ABC cells can safely be given to adults with KRAS G12V-mutated metastatic cancers to see if it can help some types of pancreatic, biliary, colorectal, or lung cancer.

  Recruiting Phase 1 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07594067

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.