Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy and safety of 1st line therapy with gemcitabine plus S1 and tislelizumab in participants with advanced biliary tract carcinoma (BTC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine plus S1 and tislelizumab | Experimental | Participants will receive gemcitabine plus S1 and tislelizumab until disease progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine (1000 mg/m2) will be administered by IV infusion on Day 1and Day 8 of each 21-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Baseline up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | baseline up to approximately 12 months | |
| 1-year survival rate | baseline up to approximately 12 months | |
| Disease control rate (DCR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haifeng XU | Contact | 18610431165 | xuhf781120@sina.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | Beijing | China |
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C079198 | S 1 (combination) |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| S1 | Drug | S1 (60 mg/day if body surface area < 1.25 m2, 80 mg/day if body surface area = 1.25~1.50 m2) will be administered by PO on Day 1 ~ 14 of each 21-day cycle |
|
| Tislelizumab | Drug | Tislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle |
|
| baseline up to approximately 6 months |
| Duration of response (DoR) | baseline up to approximately 12 months |
| Percentage of participants with SD ≥ 4 weeks | baseline up to approximately 6 months |
| 3-month progression free survival rate | baseline up to approximately 3 months |
| 6-month progression free survival rate | baseline up to approximately 6 months |
| 6-month overall survival rate | baseline up to approximately 6 months |
| 12-month overall survival rate | baseline up to approximately 12 months |
| Quality of life (QoL) | baseline up to approximately 12 months |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |