Advanced Biliary Tract CancerPhase 2ZSAB-GENTLENCT07897565
Safety and Efficacy of Gemcitabine, Toripalimab and Dose- Modified Lenvatinib in Elderly Patients With Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy
A Phase 2 study testing gemcitabine, toripalimab, and lenvatinib capsules in people with Advanced Biliary Tract Cancer, run by Shanghai Zhongshan Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Advanced Biliary Tract Cancer
- What is being tested?
- gemcitabine, toripalimab, and lenvatinib capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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.
- 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.
About this study
Official title: 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
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.
- Conditions
- Advanced Biliary Tract Cancer
- Being tested
- gemcitabine, toripalimab, and lenvatinib capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine, toripalimab, and lenvatinib capsulesDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Elderly Participants with Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy | Experimental | Not described Receives: Drug: gemcitabine, toripalimab, and lenvatinib capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 39 months.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 39 months.
QoL assessment 1
Impact on quality of life (Quality of Life Scores) assessed by EORTC QLQ-C30
Measured: Up to 25 months.
QoL assessment 2
Impact on quality of life (Quality of Life Scores) assessed by EORTC QLQ-BIL21
Measured: Up to 25 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897565
- Sponsor's protocol ID
- B2026-267R
- Acronym
- ZSAB-GENTLE
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07897565
- Acronym / sponsor ID
- ZSAB-GENTLE / B2026-267R
- Conditions
- Advanced Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Participants with Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy | Experimental | Drug: gemcitabine, toripalimab, and lenvatinib capsules |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine, toripalimab, and lenvatinib capsulesThe 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). | Drug | Elderly Participants with Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy |
Primary outcome
ORR by RECIST v1.1
Time frame: Up to 39 months.
Objective response rate (ORR) is defined as complete response (CR) rate + partial response (PR) rate according to RECIST v1.1.
8 secondary outcomes
DCR by RECIST v1.1
Time frame: Up to 39 months.
DOR by 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 frame: From the date of enrollment until the date of first documented disease progression, assessed up to 39 months.
PFS by RECIST v1.1
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
Time frame: From the date of enrollment until the date of death from any cause, assessed up to 39 months.
ORR by iRECIST
Time frame: Up to 39 months.
QoL assessment 1
Time frame: Up to 25 months.
QoL assessment 2
Time frame: Up to 25 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Biliary Tract Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
RecruitingPhase 2
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine, toripalimab, and lenvatinib capsules in people with Advanced Biliary Tract Cancer, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR by RECIST v1.1 (time frame: Up to 39 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.