Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas

Sponsor
West China Hospital
Study ID
NCT06654297
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    Camrelizumab will be given at at a dose of 200 mg intravenously on day 23 of a planned 28-day cycle, and two doses before surgery.
  • Palbociclib(100mg) — DRUG
    Palbociclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for three cycles.
  • Palbociclib(125mg) — DRUG
    Palbociclib will be given at a dose of 125 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for three cycles.

Study Details

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Palbociclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC).

Key Dates

Start date
Oct 27, 2024
Status verified
Mar 2026
Primary completion
Jun 3, 2025
Completion
Feb 7, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+Palbociclib(100mg) 3 patients
    For palbociclib, there is 2 dose levels, 100mg qd and 125 mg qd, and if no patients experience DLT on 100mg level, 125mg level will be administered.
  • Experimental: Camrelizumab+Palbociclib(125mg) 3 patients
    For palbociclib, there is 2 dose levels, 100mg qd and 125 mg qd, and if no patients experience DLT on 100mg level, 125mg level will be administered.

Primary Outcome Measure

Safety of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events [ Time Frame: up to 15 weeks ]

Related Studies