Status:
ACTIVE_NOT_RECRUITING
Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsors:
AstraZeneca
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The aim of this study is to assess the efficacy and safety of durvalumab combined with S-1 as adjuvant therapy of resectable Biliary Tract Cancer(BTC) with high risk of recurrence
Detailed Description
Radical surgical resection is still the most important radical treatment for biliary tract tumors, and the postoperative recurrence rate of BTC patients remains high. It is particularly important to c...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, both males and females are eligible.
- Intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer(Histologically confirmed).
- TNM stage before surgery: GBC/DCC T2-T4, N+, M0; ICC T1b-T4, N+, M0; PCC, any T, any N, M0 (according to UICC/AJCC TNM staging (8th edition)) .
- Patients must undergo radical resection, including liver resection or pancreatectomy, before enrollment.
- Time between surgery and enrollment \< 12 weeks.
- R0 resection.
- ECOG PS 0-1.
- No distant metastasis confirmed by MRI.
- Adequate organ and marrow function, as defined below. Haemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1.5 × 109/L Platelet count ≥ 100 × 109/L Serum bilirubin ≤ 1.0 × ULN ALT and AST ≤ 2.5 × ULN Calculated creatinine clearance \> 50 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance.
Exclusion
- Patient diagnosed with Ampulla of Vater(AoV).
- Time between surgery and enrollment \>12 weeks.
- Receive anti-tumor treatment before surgery, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, local therapy, etc.
- The tumor was not completely removed, or the postoperative pathology indicated that it was not a biliary tract tumor.
- Receive other anti-tumor treatments, such as chemotherapy, radiotherapy, or other research drugs, during postoperative adjuvant therapy.
- Severe infection within 4 weeks before enrollment.
- Participated in another interventional clinical study.
- Other factors deemed by the investigator to make the participant unsuitable for participation in this study.
Key Trial Info
Start Date :
May 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06490107
Start Date
May 24 2024
End Date
December 30 2027
Last Update
July 8 2024
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China