Clinical trial · Observational
Prospective Observational Study to Predict the Response of Biliary Tract Tumors to Immunotherapy
Prospective Observational Study on Prediction of Response to First-line Immunotherapy in Patients With Biliary Tract Tumors
NCT06048289CI-TRIAL-00069884unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective, observational study to explore multidimensional biomarkers for predicting the efficacy of immunotherapy In biliary tract tumors
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Tumor | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples, tumor biopsy specimens will be collected | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Immunotherapy combined with chemotherapy
- interventionNames
- Other: Blood samples, tumor biopsy specimens will be collected
Primary outcomes (1)
- measure
- Identifying predictive biomarkers of immunotherapy response
- timeFrame
- 1 year
- description
- ldentifying predictive biomarkers of immunotherapy response by detecting differences in genome and transcriptome sequencing between responder and non-responder patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Over 18 years old; 2. Imaging evaluation indicates unresectable advanced or metastatic biliary tract tumors (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma); 3. Confirmed as adenocarcinoma by histology; 4. Has not received systemic therapy in the past (patients who have not progressed within six months after the completion of neoadjuvant therapy or adjuvant therapy can be enrolled); 5. At least one measurable lesion according to RECIST 1.1 standard; 6. Plan to receive PD-1/PD-L1 inhibitors combined with chemotherapy as first-line treatment; 7. Sign informed consent, has good compliance and can cooperate with follow-up. Exclusion Criteria: 1. Suffering from other active malignant tumors within 5 years or simultaneously; Unable to collect baseline plasma or tissue samples.
References
Publications (1)
- DERIVEDXu Q, Zhou S, Zhang C, Zhou Y, He Y, Jiang Y, Li J, Yi T, Luo C, Zhang L, Wu J, Zhang Y, Wu M, Wei Q, Li Q, Liu B, Chen X, Yao Y, Yu C, Li J, Ren Y, Zhuo W, Yuan L, Li W, Wang ZM, Li B, Xia M, Xie Y, Wu K, Ying J. Ivonescimab plus gemcitabine and cisplatin as first-line therapy for advanced biliary tract cancer: a multicenter, open-label phase 2 trial. J Hepatol. 2026 Jul 6:S0168-8278(26)02682-6. doi: 10.1016/j.jhep.2026.06.033. Online ahead of print. PMID 42409321