Camrelizumab Combined With Radiotherapy for Adjuvant Treatment of Esophageal Squamous Cell Carcinoma After Surgery

A Single-arm, Exploratory Clinical Study of Camrelizumab Combined With Radiotherapy for Adjuvant Treatment of Esophageal Squamous Cell Carcinoma After Surgery

This is an investigator-initiated, single-arm, single-center, exploratory clinical study.The study population consisted of patients with R0 resection of esophageal squamous cell carcinoma who had not received radiation therapy.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with radiotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.About 20 subjects are planned to be enrolled in this study.Drug regimen: Patients with esophageal squamous cell carcinoma received radiotherapy combined with carrilizumab adjuvant therapy for 6 cycles 1-3 months after R0 resection.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Squamous Cell Carcinomas
• Intervention / Treatment: Drug: Camrelizumab; Radiation: radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhichao Fu, Prof; Phone Number: 13774562945; Email: fauster1112@126.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • Recruiting
      • Fuzhou General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 - 75 year，male or female；
• The clinical stages of esophageal squamous cell carcinoma diagnosed by pathology (including histology or cytology) were T1-4AN0M0 and T1-4AN +M0
• Patients who underwent surgical resection and were assessed as R0.However, patients who have received previous radiotherapy should be excluded
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
• Survival expectation ≥ 3 months;

• The laboratory test value of the patient before medication should meet the following standards:

  1. Routine blood：WBC≥3.0 × 109/L；ANC≥1.5 × 109/L；PLT≥90 × 109/L；HGB≥9.0 g/dL；
  2. Liver function：TBIL≤1.5 × ULN，AST≤2.5 × ULN，ALT≤2.5 × ULN（Subjects with liver metastasis，AST≤5× ULN，ALT≤5 × ULN）；
  3. Renal function：Cr≤1.5 × ULN or CrCl ≥50 mL/min；
  4. Blood coagulation function：INR≤1.5，APTT≤1.5 ×ULN ；
• Women of childbearing age must have a serum pregnancy study within 2 weeks prior to the first dose and the results are negative. Female subjects of childbearing age and partners who are women of childbearing age must be contraceptive during the study period and within 180 days after the last administration of the study drug;

Exclusion Criteria:

• Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)
• Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation；
• Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction；
• There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia；
• Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above；
• Has not fully recovered from toxicity and/or complications from any intervention prior to initiation of treatment (i.e., ≤ grade 1 or level required at baseline, excluding fatigue or hair loss);
• Allergic reactions to test drugs for this application；
• Pregnant or lactating women；
• Those whom the investigator considered unsuitable for inclusion。

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: treatment group; The adjuvant treatment of radiotherapy combined with carrilizumab lasted for 6 cycles	Drug: Camrelizumab; PD-1antibodies，200mg ivgtt Q3W; Radiation: radiotherapy; 45-55Gy/1.8～2.0Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year disease-free survival rate (1-year DFS)	The percentage of subjects who were free of disease recurrence or death from the start of study enrolment to 12 months later.	up to approximately 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	the time from treatment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.	up to approximately 2 year
Disease-free survival (DFS)	The time from enrolment (ICF signing) to disease recurrence or death due to disease progression.	up to approximately 2 year
Overall survival (OS)	the time between subjects' death from various causes.For subjects still alive at the last follow-up, their OS was measured as data deletion by the time of the last follow-up.	up to approximately 3 year

Collaborators and Investigators

• Sponsor: Fuzhou General Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (ACTUAL): February 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: OBU-FJ-BC-EC-II-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No