NCT07897565Not yet recruitingPhase 2
Safety and Efficacy of Gemcitabine, Toripalimab and Dose- Modified Lenvatinib in Elderly Patients With Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy
Safety and Efficacy of Gemcitabine, Toripalimab and Dose- Modified Lenvatinib in Elderly Patients With Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy: A Multicenter, Single-Arm, Phase II Exploratory Clinical Trial
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if the regimen of gemcitabine, toripalimab and dose-modified lenvatinib works to treat advanced biliary tract cancer in elderly patients with intolerance to conventional chemotherapy. It will also learn about the safety of the regimen. The main questions it aims to answer are: * Does this regimen control the tumors in participants with advanced biliary tract cancer? * What medical problems do participants have when taking this regimen? Participants will: Take lenvatinib capsules every day, gemcitabine on days 1 and 8, and toripalimab on day 1 every 3 weeks; Visit the clinic regularly for follow-ups, imaging scans, and lab tests.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- First submitted
- 8 Oct 2026
- Start date
- 12 Oct 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07897565
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 39
- From 12 Oct 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior anti-tumor therapy before the first study dose;
- Participation in another clinical study within 4 weeks before the first study dose;
- Ampullary carcinoma or other pathological types of malignancy besides the study disease, other malignancies, CNS metastases, transplant history, prior antitumor local therapy, recent participation in other clinical studies or major surgery, or unresolved toxicity from prior therapy.
Other illness
- Participants with severe comorbidities, immunodeficiency, autoimmune disease, uncontrolled infection, bleeding or thrombotic risks, or other risk factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
Who the study is looking for
- Age ≥ 65 years at the time of informed consent, male or female;
- ECOG performance status (PS) score of 0 or 1;
- Expected survival ≥ 12 weeks;
- Histologically or cytologically confirmed locally advanced or recurrent/metastatic advanced biliary tract malignancy (BTC), including intrahepatic cholangiocarcinoma (iCCA), extrahepatic cholangiocarcinoma (eCCA), and gallbladder carcinoma (GBC) by a complete pathology report from a qualified/accredited institution;
- Participants are not candidates for surgical resection, ablation, or similar local therapies;
- Cancer and Aging Research Group (CARG) chemotherapy risk score \< 10;
- No prior systemic anti-tumor therapy for the study disease;
- Participants must provide sufficient tumor samples (within 6 months) from the primary or metastatic lesionbefore the first study dose for exploratory biomarker testing;
- At least one measurable lesion according to RECIST v1.1;
- Have adequate laboratory parameters and organ functions during the screening period.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.