Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinoma

NCT07191977 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-417
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief 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

Esophageal Squamour Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Major Pathologic Response

  Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells.

  up to 15 weeks

Secondary Outcomes (5)

• Pathological Complete Response (PCR)

  up to 15 weeks

• Overall survival (OS)

  Up to 2 years

• Objective response rate (ORR)

  up to 15 weeks

• R0 resection rate

  up to 15 weeks

• Incidence of Treatment-Emergent Adverse Events

  from the first dose to within 30 days after the last dose

Study Arms (1)

Camrelizumab+Palbociclib(100mg)

EXPERIMENTAL

Drug: Camrelizumab; Drug: Palbociclib

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.

Camrelizumab+Palbociclib(100mg)

Palbociclib 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.

Camrelizumab+Palbociclib(100mg)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Interventions

camrelizumab; palbociclib

Study Officials

• Jin Zhou

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Zhou

CONTACT

+8613880626596; zhoujin096@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 25, 2025

Record last verified: 2025-09