Actively Recruiting
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-01-16
122
Participants Needed
4
Research Sites
52 weeks
Total Duration
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
J
Jinling Hospital, China
Collaborating Sponsor
Cholangiocarcinoma is a cancer that originates in the bile ducts, and its main treatment is surgical removal of the tumor. Despite advances in imaging and surgical techniques, the rate of successful surgery and long-term survival remain low due to high recurrence after surgery. This trial investigates whether adding the drug Adebrelimab combined with capecitabine as a postoperative treatment can improve outcomes in patients with high-risk resected cholangiocarcinoma. Participants will be randomly assigned to one of two groups: one receiving Adebrelimab plus capecitabine and the other receiving capecitabine alone. Adebrelimab is given intravenously every three weeks at a dose of 1200 mg for one year. Capecitabine is taken orally twice daily on days 1 to 14 of a 21-day cycle for 6 to 8 cycles. This study is open-label and multicenter, focusing on comparing the safety and effectiveness of these treatment approaches after surgery. During the study, participants will undergo regular assessments including imaging to check for tumor recurrence, laboratory tests, and monitoring for side effects. The primary goal is to measure the rate of recurrence-free survival one year after treatment begins. Secondary outcomes include overall survival over three years, recurrence-free survival over two years, and minimal residual disease monitoring. The total study duration includes all treatment cycles and follow-up assessments up to three years to evaluate long-term effects and safety.
CONDITIONS
Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year for Adebrelimab and capecitabine; 6 to 8 cycles (approximately 18 to 24 weeks) for capecitabine alone
Participants receive adjuvant therapy with either Adebrelimab combined with capecitabine or capecitabine alone after surgery to reduce the risk of cancer recurrence.
Visits every 3 weeks during treatment cycles
Duration - Up to 2 years
Participants are monitored for recurrence-free survival, overall survival, and safety after completing treatment.
Regular visits for assessments during the follow-up period
Total: 4 locations
1
Jinling Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
2
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210002
Actively Recruiting
3
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 240000
Not Yet Recruiting
4
Yancheng NO.1 People's Hospital
Yancheng, Jiangsu, China, 280000
Not Yet Recruiting
X
Xiangcheng Li, Prof. M.D.
C
Changxian Li, Prof. M.D.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Yuan Cheng, Yaodong Zhang, Changxian Li...
https://pubmed.ncbi.nlm.nih.gov/40738506