NCT06607276

Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE

A Phase 2, Randomized, Controlled, Multicenter Study of Adjuvant Adebrelimab Combined With Capecitabine in Resected Cholangiocarcinoma With High-risk Factors: ACHIEVE

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Biliary tract malignancies (BTC) are malignant tumors that originate from the epithelium of the bile ducts. Currently, the optimal treatment for biliary tract malignancies is radical surgical resection. In recent years, with the advancement of imaging technology and surgical techniques, there has been certain progress in the diagnosis and treatment of biliary tract malignancies. However, the surgical resection rate and long-term survival rate after surgery are still not satisfactory, and the high postoperative recurrence rate is an important factor affecting the long-term survival of patients. Therefore, there is an urgent need to explore new postoperative adjuvant treatment plans to reduce postoperative tumor recurrence, which is of great significance for extending the survival of patients with biliary tract malignancies. In the NCCN and CSCO guidelines, capecitabine is listed as a category I recommendation for adjuvant treatment of biliary tract malignancies (BTC). However, in clinical practice, the use of capecitabine or tegafur for postoperative patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate. Therefore, there is still a huge unmet need in the clinical adjuvant treatment after surgery for biliary tract malignancies. Based on the above background, we plan to carry out a randomized, open, and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery, and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma.

Detailed description

Postoperative adjuvant therapy for biliary system tumors has long lacked a universally recognized standard regimen. The BILCAP trial results showed a survival benefit with adjuvant therapy. The BILCAP study filled the gap in the field of postoperative adjuvant therapy for biliary system tumors. In the study, the median overall survival (OS) in the capecitabine group was 51.1 months, compared to 36.4 months in the observation group. The median recurrence-free survival (RFS) in the capecitabine group was 24.4 months, compared to 17.5 months in the observation group. Compared to the observation group, adjuvant therapy with capecitabine significantly prolonged both OS and RFS, and the capecitabine group had good tolerability with no chemotherapy-related deaths. In addition, the ASCOT study reported that adjuvant therapy with tegafur after surgery could prolong the RFS rate in patients. Therefore, in the NCCN and CSCO guidelines, capecitabine is listed as a category I recommendation for adjuvant therapy of biliary tract malignancies (BTC). However, it is regrettable that the latest reports show that in the intention-to-treat (ITT) population, the BILCAP trial failed to reach its primary endpoint of OS, with the median OS in the study group and the control group being 51.1 months and 36.4 months, respectively \[HR=0.81, 95% CI(0.63,1.04), P=0.097\]. Furthermore, in clinical practice, the use of capecitabine or tegafur after surgery in patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate. Therefore, there is still a significant unmet need in the clinical postoperative adjuvant therapy for biliary tract malignancies.Based on the above background, we plan to carry out a randomized, open, and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery, and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma.

Conditions

• Cholangiocarcinoma Cancer
• Adebrelimab (SHR-1316)

Interventions

Type	Name	Description
DRUG	Adebrelimab and capecitabine	Adebrelimab: 1200mg, IV, q3w for one year; capecitabine:1250mg/m2, po, bid,d1-14, q3w, for 6-8 cycles
DRUG	capecitabine	capecitabine:1250mg/m2, po, bid,d1-14, q3w, for 6-8 cycles

Timeline

• Start date: 2024-09-20
• Primary completion: 2026-09-20
• Completion: 2027-09-20
• First posted: 2024-09-23
• Last updated: 2025-01-16

Locations

4 sites across 1 country: China