Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC

NCT06490107 | Active Not Recruiting Phase 2

• 1 other identifier: NCC4584
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Biliary Tract Cancer

Keywords

Resectable Biliary Tract Cancer; High Risk of Recurrence; Adjuvant therapy; Immunotherapy combined with chemotherapy

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence-free survival rate

  The 2-year recurrence-free survival rate refers to the proportion of patients who did not experience disease recurrence within 2 years after surgery.

  2 years

Secondary Outcomes (4)

• Overall survival（OS）

  3 years

• Recurrence-free survival(RFS)

  2 years

• 3-year overall survival rate(3-year OS rate)

  3 years

• Safety and tolerability by incidence, severity and outcome of adverse events

  3 years

Study Arms (1)

Durvalumab combined with S-1

EXPERIMENTAL

Durvalumab combined with S-1

Drug: Durvalumab combined with S-1

Interventions

Durvalumab combined with S-1 DRUG

The treatment regimen for this study is as follows: First 8 cycles of adjuvant therapy: Durvalumab 1500mg, (Day 1, IV, Q3W) and S-1 40mg/m2 (Day1-14, BID, Q3W), up to 8 cycles. Maintenance therapy stage(6 cycles)：If the patients do not experience disease recurrence or intolerance after first 8 cycles of adjuvant therapy, then, Durvalumab 1500mg, (IV, Q4W), up to 6 cycles

Also known as: PD-L1+S-1

Durvalumab combined with S-1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• AstraZeneca: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Yongkun Sun

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-06

Locations

CN (1)