Trial · NCT07437287
Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers
NCT07437287, Phase 2, Phase 3, Not yet recruiting, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers. Trials, record NCT07437287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07437287
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers
- NCT number
- NCT07437287
- Status
- Not yet recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 160 participants, estimated
- Lead sponsor
- UNICANCER
- Conditions
- Biliary Tract Cancer (BTC)
- Interventions
- mFOLFOX regimen, Mitazalimab
- First posted
- 2026-02-27
- Last updated
- 2026-02-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6 months overall survival rate of participants | From randomisation to 6 months after randomisation | Proportion of participant still alive 6 months after randomisation |
| Secondary | Safety of the treatments | From inclusion to completion of the study, up to 64 months | Adverse events will be collected and scored according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) common criteria v 6.0. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders. |
| Secondary | Objective response rate of participants (ORR) | Time from randomisation to disease progression, up to 64 months | The objective response rate is defined as the percentage of participants with a complete response (CR) or a partial response (PR) on CT-scan for a given treatment |
| Secondary | Disease control rate (DCR) | Time from randomisation to disease progression, up to 64 months | Proportion of participants with stable disease, or partial response or complete response on CT-Scan |
| Secondary | Progression-free survival (PFS) | Time from randomisation to disease progression or death, up to 64 months | The Progression free survival is the lengh of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse |
| Secondary | Duration of overall response (DOR) | Time from randomisation to disease progression or death, up to 64 months | Time from first documented response (compared to baseline measurement taken at randomisation) until the date of disease progression or death from any cause, whichever occurs first |
| Secondary | Overall survival (OS) | From randomisation to death from any cause, up to 64 months | The overall survival is the length of time from randomization that patients enrolled in the study are still alive. |
| Secondary | Quality of life questionnaire - Core Function 17 (QLQ-F17) | Baseline and every 2 months during the first year after randomisation | Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire contains 15 items organized into five functional scales (physical, everyday activity, cognitive, emotional, and social) and 2 items for health/quality of life overall scale. The 15 items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much") and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. The 2 last items for health/quality of life overall are rated on 7 point scale (from 1 = "very poor" to 7 = "excellent") |
| Secondary | Quality of life Questionnaire - Biliary tract cancer module (QLQ-BIL21) | Baseline and every 2 months during the first year after randomisation | This EORTC cholangiocarcinoma and gallbladder cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BIL21 contains 21 items to assess symptoms. 3 single-item assessments relating to treatment side effects, difficulties with drainage bags/tubes and concerns regarding weight loss, and 18 items grouped into 5 scales: eating symptoms (4 items), jaundice symptoms (3 items), tiredness (3 items), pain symptoms (4 items) and anxiety symptoms (4 items). All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. |
| Secondary | The Developed 5-level version of EQ-5D (EQ-5D-5L) questionnaire | At Baseline and every 2 months during the first year after randomisation | Developed by the EuroQol group, the self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials consists of a descriptive system and a visual analogue scale (VAS). The EQ-5D-5L descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each dimension has 5 levels (1 = "no problems", 2 = "slight problems", 3 = "moderate problems", 4 = "severe problems", and 5 = "extreme problems"). This questionnaire provide a 5-digit score which generate a health state profile. The VAS records the patient's self-rated health on a vertical visual analogue scale where the score range from 0 (The best health you can image) to 100 (The worst health you can image). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement. |
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/NCT07437287
GET https://conductscience.org/api/trials/v1/NCT07437287/registered