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Not Yet RecruitingNCT07191977

Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinoma

Neoadjuvant Camrelizumab With Palbociclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
41 (estimated)
Sponsor
West China Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The goal of this Phase 2 clinical trial is to learn if the combination of Camrelizumab and Palbociclib is a safe and effective treatment when given before surgery (neoadjuvant therapy) for patients with esophageal squamous cell carcinoma (ESCC) that can be surgically removed. Camrelizumab is an immunotherapy drug that helps the immune system fight cancer, and Palbociclib is a targeted therapy drug that stops cancer cells from growing. The main questions it aims to answer are: Is the combination of Camrelizumab and Palbociclib safe for patients to receive before their surgery? How effective is this treatment combination in shrinking tumors prior to surgery?

Conditions

Interventions

TypeNameDescription
DRUGCamrelizumabCamrelizumab 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.
DRUGPalbociclibPalbociclib 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.

Timeline

Start date
2026-01-01
Primary completion
2027-12-01
Completion
2029-12-01
First posted
2025-09-25
Last updated
2025-09-25

Source: ClinicalTrials.gov record NCT07191977. Inclusion in this directory is not an endorsement.