Trial · NCT07897565
Safety and Efficacy of Gemcitabine, Toripalimab and Dose- Modified Lenvatinib in Elderly Patients With Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy
NCT07897565, Phase 2, Not yet recruiting, Shanghai Zhongshan Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Gemcitabine, Toripalimab and Dose- Modified Lenvatinib in Elderly Patients With Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy. Trials, record NCT07897565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07897565
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Gemcitabine, Toripalimab and Dose- Modified Lenvatinib in Elderly Patients With Advanced Biliary Tract Cancer Intolerant to Conventional Chemotherapy
- NCT number
- NCT07897565
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 39 participants, estimated
- Lead sponsor
- Shanghai Zhongshan Hospital
- Conditions
- Advanced Biliary Tract Cancer
- Interventions
- gemcitabine, toripalimab, and lenvatinib capsules
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR by RECIST v1.1 | Up to 39 months. | Objective response rate (ORR) is defined as complete response (CR) rate + partial response (PR) rate according to RECIST v1.1. |
| Secondary | DCR by RECIST v1.1 | Up to 39 months. | Disease control rate (DCR) is defined as complete response (CR) rate + partial response (PR) rate + stable disease (SD) rate according to RECIST v1.1. |
| Secondary | DOR by RECIST v1.1 | 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. | 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. |
| Secondary | TTP by RECIST v1.1 | From the date of enrollment until the date of first documented disease progression, assessed up to 39 months. | Time to progression (TTP) is defined as time from enrollment to disease progression according to RECIST v1.1. |
| Secondary | PFS by RECIST v1.1 | 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. | Progression-free survival (PFS) is defined as time from enrollment to disease progression assessed (according to RECIST v1.1) or death from any cause. |
| Secondary | OS | From the date of enrollment until the date of death from any cause, assessed up to 39 months. | Overall survival (OS) is defined as time from enrollment to death from any cause. |
| Secondary | ORR by iRECIST | Up to 39 months. | Objective response rate (ORR) is defined as complete response (CR) rate + partial response (PR) rate according to iRECIST. |
| Secondary | QoL assessment 1 | Up to 25 months. | Impact on quality of life (Quality of Life Scores) assessed by EORTC QLQ-C30 |
| Secondary | QoL assessment 2 | Up to 25 months. | Impact on quality of life (Quality of Life Scores) assessed by EORTC QLQ-BIL21 |
| Other | Safety assessment | Up to 39 months. | Number of Participants With Adverse Events as Assessed by CTCAE v6.0 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07897565
GET https://conductscience.org/api/trials/v1/NCT07897565/registered