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

Sponsor
Henan Cancer Hospital
Study ID
NCT06231680
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity
  • Thalidomide 50mg — DRUG
    Thalidomide 50mg，po qd；
  • Thalidomide 100mg — DRUG
    Thalidomide 100mg，po qd；
  • Thalidomide 200mg — DRUG
    Thalidomide 200mg，po qd；
  • Chemotherapy — DRUG
    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.

Study Details

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

Key Dates

Start date
Jan 19, 2024
Status verified
Jan 2024
Primary completion
Jun 30, 2024
Completion
Sep 30, 2025

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Prevention Cohort 1 Group A
    Camrelizumab + chemotherapy+Thalidomide(50mg)
  • Experimental: Prevention Cohort 1 Group B
    Camrelizumab + chemotherapy+Thalidomide(100mg)
  • Experimental: Treatment Cohort 2 Group A
    Thalidomide(100mg)
  • Experimental: Treatment Cohort 2 Group B
    Thalidomide(200mg)

Primary Outcome Measure

Incidence rate of RCCEP [ Time Frame: 2 years ]

Central Contacts

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