Clinical trial · Interventional
Adjuvant PD-1 Antibody in Combination With Capecitabine for Patients With ICC at High-Risk of Postoperative Recurrence
Adjuvant PD-1 Antibody（Tislelizumab） in Combination With Capecitabine for Patients With Cholangiocarcinoma at High-Risk of Postoperative Recurrence
NCT04782804CI-TRIAL-00060386unknownPhase 1 / Phase 2ClinicalTrials.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)
The purpose of the study is to observe the effect of PD-1 Antibody（Tislelizumab） Combined With Capecitabine as Adjuvant Therapy to Prevent the Recurrence in High-risk Patients With Cholangiocarcinoma After Curative Resection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma, Intrahepatic | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| PD-1 Antibody（Tislelizumab） | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Capecitabine
- description
- Capecitabine as Adjuvant Therapy Oral capecitabine (1250 mg/m²) was given post operatively twice a day on days 1 to 14 of a 3-weekly cycle for 24 weeks (eight cycles), and observation commenced within 16 weeks of surgery.
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- Capecitabine+PD-1 Antibody（Tislelizumab）
- description
- Capecitabine+PD-1 Antibody（Tislelizumab）as Adjuvant Therapy Oral capecitabine (1250 mg/m²) was given post operatively twice a day on days 1 to 14 of a 3-weekly cycle for 24 weeks (eight cycles), and observation commenced within 16 weeks of surgery. PD-1 Antibody（Tislelizumab, 200mg） was given q3w iv.
- interventionNames
- Drug: Capecitabine
- Drug: PD-1 Antibody（Tislelizumab）
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Post R0 resection, pathologically confirmed intrahepatic cholangiocarcinoma.Patients were also pathologically confirmed to have any of the following high-risk factors (ie, positive resection margins, positive lymph nodes, positive perineural invasion, and intrahepatic cholangiocarcinoma \> 5cm in diameter; * No history of any chemotherapy, radiotherapy, immunotherapy and interventional treatment prior to surgical resection; * ECoG score 0-1 points; * Liver function before medication child a, blood routine: WBC \> 2.5 \* 109 / L, PLT \> 60 \* 109 / L, coagulopathy: Pt prolonged \< 2S, ALT \< 150u / L; * No heart, lung, or kidney function abnormalities were observed; * No history of major bleeding disorders of the digestive tract; * Signed informed consent; Exclusion Criteria: * Pregnant or lactating women. * Patients with other malignant tumor. * Patients with mental illness. * Patients participated in other clinical trials in last three months. * Residual lesions showed by Postoperative digital subtraction angiography(DSA). * Postoperative patients treated with other targeted drugs, PD1 antibody and other immunotherapies, FOLFOX systemic chemotherapy, and HuaiErKeLi drug treatment
References
Publications (0)
Data not yet available
No reference posted for this study.