A Prospective, Randomized, Open, Phase II Clinical Study of Chidamide in Combination with Camrelizumab and Apatinib for Advanced Esophageal Cancer

Sponsor
Peking University
Study ID
NCT06745193
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Esophageal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study aims to evaluate the efficacy and safety of a combination treatment of chidamide, camrelizumab, and apatinib in patients with advanced esophageal cancer. This open-label, phase II clinical trial will involve randomly assigning participants to receive either the combination of these drugs or a standard treatment. The primary endpoints is ORR and the second endpoints include progression-free survival and overall survival, while safety will also be assessed.

Key Dates

Start date
Feb 1, 2025
Status verified
Nov 2024
Primary completion
Feb 1, 2027
Completion
Feb 1, 2028

Study Design

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

Arms

  • Experimental: chidamide+Camrelizumab+Apatinib
  • Placebo Comparator: SOC
    Irinotecan or Docetaxel or Paclitaxel

Primary Outcome Measure

Objective Response Rate（ORR） [ Time Frame: up to 24 months ]

Central Contacts

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