NCT05430698

PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma

PD-1 Antibody Plus Gemcitabine and Oxaliplatin (GEMOX) as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma Patients With Positively Metastatic Lymph Nodes : a Single Arm, Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.

Detailed description

For perihilar cholangiocarcinoma, radical surgical treatment, such as major hepatectomy combined with total caudate lobe and extrahepatic bile duct resection, remain the potential modality for cure. However, the lymph node tumor metastasis is an independent risk factor for prognosis after radical resection for this disease without distant metastasis. As reported by Nagoya University, Japan, the patients without lymph node tumor metastasis, the 5-year survival rate could reach as high as 67.1% after R0 resection, but the 5-year survival rate was only 22.1% for the patients with lymph node tumor metastasis after R0 resection. Thus, it is urgent to look for an effective adjuvant therapy treatment for these patients with lymph node tumor metastasis. Fluoropyrimidine-based or gemcitabine-based chemotherapy was recommended for these patients by NCCN guidelines. Studies have shown that Gemox chemotherapy (oxaliplatin + gemcitabine) in patients with resected biliary tract cancer has a good benefit in overall survival. However, for extrahepatic cholangiocarcinoma with lymph nodes metastasis, the benefit was limited. In recent years, immunotherapy, such as PD-1 or PD-L1 monoclonal antibody, combined with chemotherapy have shown better results in the palliative treatment of un-resectable biliary tract tumor. However, there is no report on combined immunotherapy with chemotherapy as adjuvant therapy in perihilar cholangiocarcinoma with lymph node tumor metastasis after R0 resection.

Conditions

• Perihilar Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	PD-1antibody plus GEMOX	1. PD-1 antibody，200mg，D1，intravenous infusion, the administration time is 60 (+15) minutes. 2. GEMOX chemotherapy : gemcitabine 1000mg/m2,D1，D8；oxaliplatin 100mg/m2,D1，intravenous infusion. 3. Three weeks is a course of treatment,a total of 6-8 courses.

Timeline

• Start date: 2023-01-31
• Primary completion: 2027-01-31
• Completion: 2027-12-31
• First posted: 2022-06-24
• Last updated: 2026-02-09

Locations

1 site across 1 country: China