NCT06208462

Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors

Neoadjuvant Therapy of HAIC（GEMOX） Combined With Adebrelimab and Lenvatinib for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors：NEO-ERA-01 Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Clinical Study on the efficacy and safety of HAIC（GEMOX）and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable Intrahepatic Cholangiocarcinoma with high-risk recurrence factors.

Detailed description

Intrahepatic cholangiocarcinoma (ICC) accounts for more than 20% of hepatic malignancies and has become the second most common primary liver tumor worldwide. The incidence of ICC is increasing annually, showing a trend to affecting younger individuals. Treatment options for ICC contain surgical resection, perioperative chemotherapy, liver-directed therapies and systemic therapy such as cytotoxic therapy, targeted therapy and immunotherapy. Adjuvant chemotherapy after ICC resection has become the standard for patients with resected ICC based on the BILCAP trial with better mOS (53 months vs. 36 months, p=0.028) and RFS (25.9 months vs. 17.4 months, p=0.0093). The rationale for neoadjuvant chemotherapy for patients with resectable ICC also suggests a potential advantage according to NEO-GAP. While the effectiveness of hepatic artery infusion chemotherapy (HAIC) has been proven in unresectable ICC, its role in resectable ICC is controversial. The TOPAZ-1 trial demonstrated the efficacy of immune checkpoint blockade in ICC. However, it remains to be seen whether combined therapy above is effective in resectable ICC. Surgical resection remains the mainstay for ICC therapy, but postoperative patients often have a high tumor recurrence rate. The median time of disease-free survival is 18.5 months, and recurrence rate is 60%-65%. Previous research suggests that the prognosis of ICC depends on several risk factors for recurrence consisting of Stage ≥ Ib (AJCC 8th), tumor size \> 5cm, multiple tumor lesions in the same lobe, presence of radiographic major vascular invasion, or lymph node involvement, technically resectable. Further investigation is needed to evaluate the effectiveness of the comprehensive treatment system, which includes HAIC (GEMOX), immunotherapy, neoadjuvant therapy, and surgical resection, for ICC with high-risk recurrence factors. The goal of this clinical trial is to assess the efficacy and safety of HAIC (GEMOX) and Lenvatinib combined with Adebrelimab neoadjuvant therapy for resectable ICC with high-risk recurrence factors. The primary end point is to evaluate the propotion of treatment completion (including neo-adjuvant therapy and surgery), and the second outcome measures include overall survival (OS), objective response rate (ORR), pathological complete response (pCR) and the recurrence free survival (RFS) of patients after treatment. In order to investigate more effective ICC therapies, participants will undergo 2-4 cycles of HAIC (GEMOX) in combination with Lenvatinib and Adebrelimab. Evaluation will be conducted every 2 cycles, and surgery will be performed when qualified. Capecitabine will be administered for 1-14 days after surgery, and regular follow-up will be conducted.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Adebrelimab	1200mg，i.v. , q3w
DRUG	Lenvatinib	8mg,qd
DRUG	Gemcitabine	800 mg/m2，q3w
DRUG	Oxaliplatin	85 mg/m2，q3w

Timeline

• Start date: 2024-01-19
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2024-01-17
• Last updated: 2025-03-03

Locations

3 sites across 1 country: China