A Prospective, Multicenter, Phase II Study on the Efficacy and Safety of Cardenilimab Combined With Chemotherapy in the Conversion Therapy of Locally Advanced Esophageal Squamous Cell Carcinoma.

Li Zhang1 site in 1 country43 target enrollmentOctober 23, 2023

ConditionsEsophageal Squamous Cell Carcinoma Neoadjuvant Therapies

InterventionsCardenilimab Combined With Chemotherapy

DrugsCardenilimab Combined With Chemotherapy

Overview

Phase: Phase 2
Intervention: Cardenilimab Combined With Chemotherapy
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Li Zhang
Enrollment: 43
Locations: 1
Primary Endpoint: Objective Response Rate
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this trial is to test the efficacy and safety of cardenilimab combined with chemotherapy in the conversion therapy of locally advanced unresectable esophageal squamous cell carcinoma.

type of study: clinical trial

Registry

clinicaltrials.gov

Start Date

October 23, 2023

End Date

December 31, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Li Zhang

Responsible Party

Sponsor Investigator

Principal Investigator

Li Zhang

Professor

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

•Sign written informed consent before implementing any trial-related procedures;
•Male or female, age ≥18 years old;
•Patients with histologically confirmed esophageal squamous cell carcinoma, diagnosed as cT4a, T4b, NXM0 according to the 8th edition of AJCC TNM staging, and assessed as initially unresectable by the surgeon;
•Have not received any systemic treatment for the current disease in the past, including surgery, anti-tumor radiotherapy, chemotherapy/immunotherapy, etc.;
•Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no contraindications to surgery
•ECOG score 0-1 points;
•Expected survival time \>6 months;
•With sufficient organ function, subjects must meet the following laboratory indicators:
•Absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor in the past 14 days;
•Without blood transfusion in the past 14 days, platelets ≥100×109/L;

Exclusion Criteria

•Other malignant diseases diagnosed within 5 years before the first dose (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has been radically resected);
•Endoscopically known signs of active bleeding in the lesion;
•Currently participating in interventional clinical research treatment, or have received other research drugs or used research equipment within 4 weeks before the first dose;
•Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another type of stimulating or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137 etc.) drugs;
•Have received systemic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose;
•Active autoimmune disease that requires systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
•Are receiving systemic glucocorticoid treatment (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are allowed;
•Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
•People who are known to be allergic to the drugs used in this study;
•Those with multiple factors that affect capecitabine (such as inability to swallow, intestinal obstruction, etc.);