A Phase Ⅱ Clinical Trial of Camrelizumab for Adjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma

NCT04533490 | Unknown Phase 2

• 1 other identifier: SHR-1210-123
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 for adjuvant treatment of resectable esophageal squamous cell carcinoma

Conditions

Resectable Esophageal Squamous Cell Carcinoma

Keywords

ESCC,Adjuvant therapy,Camrelizumab

Outcome Measures

Primary Outcomes (2)

• RFS(relapse free survival)

  Recurrence free survival of resectable esophageal squamous cell carcinoma treated with SHR-1210

  up to 1 year

• DFS（disease-free survival）

  Disease-free survival of resectable esophageal squamous cell carcinoma treated with SHR-1210

  up to 1 year

Secondary Outcomes (1)

• OS（overall survival rate）

  At time of surgery

Other Outcomes (1)

• Exploratory analysis of biomarkers for predicting efficacy

  At time of surgery

Study Arms (1)

SHR-1210

EXPERIMENTAL

After the subjects were enrolled in the study, the patients were treated with SHR-1210 (200mg ivgtt q3w) from 1 to 2 months after operation until disease progression or intolerable toxicity, and the longest medication period was no more than 12 months

Drug: SHR-1210

Interventions

SHR-1210 DRUG

After the subjects were enrolled in the study, the patients were treated with SHR-1210 200mg igvtt q3w from 1 to 2 months after operation until disease progression or intolerable toxicity, and the longest medication period was no more than 12 months

SHR-1210

Eligibility Criteria

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

You may qualify if:

• Histology confirmed as esophageal squamous cell carcinoma;
• The clinical stages are cT1b-T4aN0M0, cT1-T4aN+M0;
• The subjects were required to complete preoperative concurrent chemoradiotherapy and complete R0 resection before enrollment;
• The shortest time of neoadjuvant therapy was 6 weeks and the longest was 12 weeks;
• Postoperative pathology: T1 or above T1, N1 or N1 above, no distant metastasis;
• Aged 18-75;
• ECOG:0-1;
• The main organs function normally, that is, the following criteria are met:
• Blood routine examination:
• HB≥90g/L; ANC ≥ 1.5 × 109 / L; PLT ≥ 80 × 109 / L;
• Biochemical examination:
• ALB ≥ 30g / L;b.ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN;c.TBIL ≤ 1.5ULN;d.plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min;
• There was no serious concomitant disease with a survival time of less than 5 years;
• Voluntary and able to comply with the protocol during the study;
• Provide written informed consent before entering the study, and patients have understood that they can withdraw from the study at any time without any loss.

You may not qualify if:

• Patients with previous or concurrent malignant tumors, except for skin basal cell carcinoma and cervical carcinoma in situ that have been cured; patients with small gastric stromal tumor and other tumors, which are judged by researchers to have no impact on the patient's life in the short term, can be excluded;
• Participated in other drug clinical trials within four weeks;
• The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis,Hyperthyroidism; patients with vitiligo ; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
• The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppressive purposes (dose\> 10 mg/day of prednisone or other therapeutic hormones) and continues to be used for 2 weeks prior to enrollment;
• Any active malignant tumor within 2 years, except for the specific cancer under study in this study and locally recurrent cancer that has been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ);
• Patients with known history of CNS metastasis or CNS metastasis before screening. For patients with clinically suspected CNS metastasis, CT or MRI must be performed within 28 days before randomization to exclude CNS metastasis;
• Patients with unstable angina pectoris history, newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events occurred within 6 months before screening; arrhythmias (including QTCF: male ≥ 450 ms, female ≥ 470 MS) need long-term use of antiarrhythmic drugs and NYHA grade ≥ II cardiac insufficiency;
• Urine routine examination showed that urinary protein was ≥ + +, and 24-hour urinary protein was more than 1.0 G;
• For female subjects: they should be surgical sterilization, postmenopausal patients, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period; the serum or urine pregnancy test must be negative within 7 days before the study enrollment, and must be non lactation period. Male subjects: they should be surgical sterilization or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period;
• The patient had received liver transplantation;
• Patients with infectious pneumonia, non infectious pneumonia, interstitial pneumonia and other patients who need to use corticosteroids;
• Have a history of chronic autoimmune diseases, such as systemic lupus erythematosus, etc;
• Patients had a history of inflammatory bowel disease such as ulcerative enteritis and Crohn's disease, and a history of chronic diarrhea such as irritable bowel syndrome;
• Patients with a history of sarcoidosis or tuberculosis;
• Patients with a history of active hepatitis B and hepatitis C and HIV infected patients;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

MeSH Terms

Interventions

camrelizumab

Study Officials

• Feng Wang

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wang

CONTACT

13938244776; fengw010@163.com

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: DOCTOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 31, 2020
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: August 23, 2021

Record last verified: 2021-08