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

NCT06231680 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-03-29

No results posted yet for this study

Summary

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

Conditions

  • Lung Cancer, Nonsmall Cell
  • Esophageal Carcinoma

Interventions

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.

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Ying Liu, MD · Henan Cancer Hospital

  • Yu Yao, MD · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-19
Primary Completion
2024-06-30
Completion
2025-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06231680 on ClinicalTrials.gov