The Safety and Efficacy of Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Squamous Cell Carcinoma.

Fujian Medical University Union Hospital1 site in 1 country25 target enrollmentNovember 10, 2021

ConditionsEsophageal Neoplasm Immunotherapy Radiotherapy

InterventionsCamrelizumab

DrugsCamrelizumab

Overview

Phase: Phase 1
Intervention: Camrelizumab
Conditions: Esophageal Neoplasm
Sponsor: Fujian Medical University Union Hospital
Enrollment: 25
Locations: 1
Primary Endpoint: Efficacy of Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an exploratory phase II clinical study designed to evaluate the safety and efficacy of Camrelizumab in combination with standard radiotherapy as preoperative neoadjuvant therapy for patients with resectable esophageal squamous cell carcinoma. In the study, all eligible subjects who meet the inclusion criteria will be enrolled after providing full informed consent and signing the informed consent form. All enrolled patients will undergo radical surgery within 4-8 weeks after completion of neoadjuvant Camrelizumab combined with standard radiotherapy.

The safety evaluation indicators include the incidence of adverse events and the number and proportion of subjects who discontinue treatment due to adverse events. The primary efficacy endpoints are the major pathological response rate and the pathological complete response rate. Based on previous studies, the expected response rate is 40% in the experimental group and 20% in the control group. Using a one-sided alpha level of 0.1 and a beta of 0.2, the calculated total sample size for the single-arm design is 25 patients, with 12 enrolled in the first stage. If 2 or fewer responders are observed in the first stage, the study will be terminated early for futility. If more than 2 responders are observed, the trial will proceed to the second stage. Upon completion of the second stage, if the total number of responders exceeds 7, the treatment will be considered effective. The need for postoperative adjuvant treatment and the specific adjuvant regimen will be determined by the investigator. All subjects are required to complete the postoperative follow-up plan as specified in the study protocol.

Registry

clinicaltrials.gov

Start Date

November 10, 2021

End Date

November 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fujian Medical University Union Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent prior to the implementation of any trial-related rocedures;
•Male or female, ≥18 years of age or ≤75 years of age;
•Patients with a confirmed diagnosis of esophageal squamous cell carcinoma by pathological histology of the primary site biopsy;
•Patients who are judged to be operable and in need of neoadjuvant therapy by imaging and esophagoscopy ( cT1b-2N+/ cT3-4aN0-3M0), stage II-IVA;
•The main body of the patient's tumor is located in the mid- and lower thoracic segment of the esophagus as judged by imaging and esophagoscopy (the central location of the tumor is horizontally below the arch of the odd vein, measured endoscopically ≥ 24 cm from the incisors);
•There is at least one imaging measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST version 1.1);
•The patient Have not received any prior antitumor therapy, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.;
•ECOG score 0-1;
•Adequate organ function, subjects need to meet the following laboratory indices:
•Absolute neutrophil count (ANC) ≥ 1.5x109/L in the last 14 days without granulocyte colony-stimulating factor ；

Exclusion Criteria

•patients with an untreated diagnosis of another malignancy within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ)
•patients at risk for tracheoesophageal fistula or aortoesophageal fistula
•currently participating in an interventional clinical study treatment or have received another study drug or been treated with an investigational device within 4 weeks prior to the first dose
•have received prior therapy with: an anti-PD-1, anti-PD-L1 or anti-PD-L2 drug or a drug targeting another stimulatory or co-suppressive T-cell receptor (e.g., CTLA-4, OX-40, CD137).
•systemic systemic therapy with a proprietary Chinese medicine or immunomodulatory agent (including thymidine, interferon, interleukin, except for local use to control pleural fluid) with an antitumor indication within 2 weeks prior to the first dose.
•active autoimmune disease requiring systemic therapy (e.g., with disease-relieving drugs, glucocorticoids, or immunosuppressive agents) that occurred within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.
•is receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study.
•Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are permitted.
•known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
•known hypersensitivity to the active ingredient or excipients of the investigational drug Camrelizumab;