Trial · NCT07062263
Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients
NCT07062263, Phase 3, Recruiting, Tata Memorial Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients. Trials, record NCT07062263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07062263
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients
- NCT number
- NCT07062263
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 220 participants, estimated
- Lead sponsor
- Tata Memorial Centre
- Conditions
- Biliary Tract Cancer, HER2-positive Cancer, Advanced Cancer, Unresectable Biliary Tract Carcinoma, Metastatic Biliary Tract Carcinoma
- Interventions
- Trastuzumab, Chemotherapy
- First posted
- 2025-07-14
- Last updated
- 2025-07-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | at 6 month after randomisation | the time from the time of diagnosis of an advanced disease to the time of disease progression or loss to follow-up or death, whichever is earlier |
| Secondary | Overall survival (OS) | at 6month, 1 year from the date of randomisation or till the time of death, lost to follow-up or last observation, whichever is earlier | the time from the time of diagnosis to the time of death, lost to follow-up or last observation, whichever is earlier |
| Secondary | Response rates | at 6th month from the date of randomisation | measured as per RECIST criteria in CE CT scan as compare with the baseline scans |
| Secondary | Quality of life (QOL) | at baseline and at completion of 4 cycles of chemotherapy (each cycle is 22 days) | measured using the EORTC-QLQ-30 questionnaires All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level |
| Secondary | Safety profile | "At the end of each Cycle (each cycle is 22 days) | side effects and adverse event profile with the combination will be reported as NCI-CTCAE v5.0 |
Source ClinicalTrials.gov
Outcomes0
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/NCT07062263
GET https://conductscience.org/api/trials/v1/NCT07062263/registered