A Phase 2 interventional study of gemcitabine, toripalimab, and lenvatinib capsules in Advanced Biliary Tract Cancer, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
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:
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.
Shanghai Zhongshan Hospital is the lead sponsor of 651 studies on the registry; 290 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Drug: gemcitabine, toripalimab, and lenvatinib capsules
The interventions include gemcitabine, toripalimab, and lenvatinib capsules. Each 21-day treatment period counts as one cycle. Gemcitabine is given for up to 8 cycles, while toripalimab and lenvatinib are given for up to 2 years. In each cycle, participants receive gemcitabine (1 g/m²) by intravenous infusion on days 1 and 8, and toripalimab (240 mg) by intravenous infusion on day 1. Lenvatinib is taken orally once daily (4 mg qd for body weight \< 60 kg, and 8 mg qd for body weight ≥ 60 kg).
This study also gives Lenvatinib. No intervention listed here names it: that was found by reading the record.
ORR by RECIST v1.1
Objective response rate (ORR) is defined as complete response (CR) rate + partial response (PR) rate according to RECIST v1.1.
Time frame: Up to 39 months.
DCR by RECIST v1.1
Disease control rate (DCR) is defined as complete response (CR) rate + partial response (PR) rate + stable disease (SD) rate according to RECIST v1.1.
Time frame: Up to 39 months.
DOR by RECIST v1.1
Duration of response (DOR) is defined as time from the first complete response (CR) or partial response (PR) to disease progression according to RECIST v1.1.
Time frame: From the date of first documented complete response (CR) or partial response (PR) ,whichever came first, until the date of first documented disease progression, assessed up to 39 months.
TTP by RECIST v1.1
Time to progression (TTP) is defined as time from enrollment to disease progression according to RECIST v1.1.
Time frame: From the date of enrollment until the date of first documented disease progression, assessed up to 39 months.
PFS by RECIST v1.1
Progression-free survival (PFS) is defined as time from enrollment to disease progression assessed (according to RECIST v1.1) or death from any cause.
Time frame: From the date of enrollment until the date of first documented disease progression or death from any cause, whichever came first, assessed up to 39 months.
OS
Overall survival (OS) is defined as time from enrollment to death from any cause.
Time frame: From the date of enrollment until the date of death from any cause, assessed up to 39 months.
ORR by iRECIST
Objective response rate (ORR) is defined as complete response (CR) rate + partial response (PR) rate according to iRECIST.
Time frame: Up to 39 months.
QoL assessment 1
Impact on quality of life (Quality of Life Scores) assessed by EORTC QLQ-C30
Time frame: Up to 25 months.
QoL assessment 2
Impact on quality of life (Quality of Life Scores) assessed by EORTC QLQ-BIL21
Time frame: Up to 25 months.
Safety assessment
Number of Participants With Adverse Events as Assessed by CTCAE v6.0
Time frame: Up to 39 months.
Number of participants with Exploratory markers
Predictive biomarker status in participants as assessed by sequencing-based analysis
Time frame: Up to 39 months.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lenvatinib