NCT06231680

Thalidomide Prevention or Treatment of Camrelizumab-induced Reactive Cutaneous Capillary Endothelial Proliferation (RCCEP)

A Prospective, Randomized Clinical Study of the Prevention or Treatment of Camrelizumab-induced Reactive Cutaneous Capillary Endothelial Proliferation (RCCEP) With Thalidomide

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To explore the dose and safety of thalidomide for the prevention and treatment of camrelizumab-induced reactive cutaneous capillary endothelial proliferation (RCCEP)

Detailed description

1. To increase the evidence of thalidomide for the prevention of RCCEP, the investigators will explore the dose of thalidomide for the prevention of RCCEP in participants with esophageal squamous cell carcinoma and non-small cell lung cancer who were scheduled to receive camrelizumab combined with platinum-based chemotherapy; 2. To increase the evidence of thalidomide for the treatment of RCCEP, the investigators will explore the dose of thalidomide for the treatment of ≥G2 RCCEP in participants with esophageal squamous cell carcinoma and non-small cell lung cancer with camrelizumab

Conditions

• Lung Cancer, Nonsmall Cell
• Esophageal Carcinoma

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity
DRUG	Thalidomide 50mg	Thalidomide 50mg，po qd；
DRUG	Thalidomide 100mg	Thalidomide 100mg，po qd；
DRUG	Thalidomide 200mg	Thalidomide 200mg，po qd；
DRUG	Chemotherapy	Platinum-based chemotherapy: 1. Esophageal squamous cell carcinoma: cisplatin/carboplatin/nedaplatin/lobaplatin+ paclitaxel/albumin-bound paclitaxel/fluorouracil on Day 1 of each 21-day cycle for 4-6 cycles; 2. Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles，pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; 3. Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles.

Timeline

• Start date: 2024-01-19
• Primary completion: 2024-06-30
• Completion: 2025-09-30
• First posted: 2024-01-30
• Last updated: 2024-03-29

Locations

2 sites across 1 country: China