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Not yet recruiting NCT07191977

Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinoma

Phase II Interventional Esophageal Squamour Cell Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Camrelizumab, Palbociclib.
Who it may be relevant to
Registry conditions: Esophageal Squamour Cell Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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?

Interventions

  • Drug Camrelizumab
    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.
  • Drug Palbociclib
    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.

Primary outcome measures

  • Major Pathologic Response [Time frame: up to 15 weeks]
Secondary outcome measures (5)
  • Pathological Complete Response (PCR) [Time frame: up to 15 weeks]
  • Overall survival (OS) [Time frame: Up to 2 years]
  • Objective response rate (ORR) [Time frame: up to 15 weeks]
  • R0 resection rate [Time frame: up to 15 weeks]
  • Incidence of Treatment-Emergent Adverse Events [Time frame: from the first dose to within 30 days after the last dose]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies.
  • The primary tumor should be located in the thorax and evaluated resectable( cT1b-T3N1-3M0, cT3N0M0) by CT/MRI/EUS
  • The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.
  • The patients should have no functional disorders in major organs. Blood routine tests, as well as lung, liver, kidney, and heart functions should be basically normal.
  • The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent.

Exclusion criteria

  • The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) and cannot be resected.
  • Currently undergoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy.
  • History of other malignancies.
  • Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
  • Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
  • Presence of serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart diseases, etc.
  • The patients with severe systematic intercurrent diseases, including active infection or poorly controlled diabetes, coagulation disorders, hemorrhagic tendency, or those undergoing thrombolysis or anticoagulant therapy etc. are excluded from the study.
  • Female participants who test positive for a serum pregnancy test, are in the lactation period, or are at a childbearing stage and unwilling to use contraception measures during the research are excluded.
  • Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
  • Any other factors that are not suitable for inclusion in this study judged by investigators.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07191977 · 2025-417

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗