A Clinical Study Of Camrelizumab With Or Without Radiotherapy In The Treatment Of Esophageal Cancer

Phase 2

• Conditions: Esophageal Cancer
• Interventions: Drug: Camrelizumab+Radiotherapy; Drug: Camrelizumab

• Registration Number: NCT04512417
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of Camrelizumab combined with or without radiotherapy for the treatment of recurrent or metastatic esophageal cancer that has progressed after chemotherapy

Detailed Description

In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. We designed a multi-center, randomized controlled, phase II clinical study of camrelizumab with or without radiotherapy for the treatment of recurrent or metastatic esophageal cancer that has progressed after chemotherapy. The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab with or without radiotherapy for advanced esophageal cancer.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Study First Posted: 2020-08-13
• Last Update Posted: 2020-08-13
• Study Start: 2020-08-31
• Primary Completion: 2021-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• 1. Volunteer to participate in clinical research: fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
• 2. Recurrent or metastatic esophageal cancer confirmed by histology or cytology, patients with ≤4 metastatic lesions;
• 3. Progress after first-line chemotherapy;
• 4. There are lesions measurable according to RECIST standards
• 5. Age ≥18 years old and ≤75 years old, regardless of gender
• 6. ECOG physical strength status score is 0～2;
• 7. Have not received immunotherapy or biological therapy before;
• 8. Hemoglobin ≥90g/L, platelets ≥10×109/L, absolute neutrophil count ≥1.5×109/L;
• 9. Serum creatinine ≤1.25 times UNL or creatinine clearance ≥60 mL/min;
• 10. Serum bilirubin≤1.5×UNL, AST (SGOT) and ALT (SGPT)≤2.5×UNL, alkaline phosphatase≤5×UNL;
• 11. No history of interstitial pneumonia or previous interstitial pneumonia;

Exclusion Criteria

• 1. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody treatment, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug;
• 2. Have received radiotherapy in the past, and the tumor in the irradiation field has progressed;
• 3. Metastasis of meninges, pleura or pericardium;
• 4. Esophageal perforation and active esophageal bleeding, with invasion of trachea and large blood vessels in the thoracic cavity;
• 5. Patients with severe cardiovascular or pulmonary diseases, interstitial pneumonia or previous history of interstitial pneumonia:
• 6. Patients who cannot understand the test requirements or may not comply with the test requirements;
• 7. Autoimmune diseases (such as: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next step of screening: type I diabetes, skin that does not require systemic treatment Diseases (such as vitiligo, psoriasis);
• 8. Active hepatitis B or C that requires treatment;
• 9. Suffered from an active infection requiring systemic treatment 14 days before the first administration;
• 10. Patients with other malignant lesions, except for curable skin cancer (non-melanoma), cervical carcinoma in situ or malignant disease cured ≥5 years;
• 11. The researcher believes that some obvious diseases should be excluded from this research;
• 12. The dose limit of radiotherapy cannot meet the limit requirement set by this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined radiotherapy group	Camrelizumab+Radiotherapy	-
Immunotherapy alone group	Camrelizumab	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) per RECIST 1.1	Up to 24 months	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Failure mode	Up to 24 months	Observe and collect the reasons for the treatment failure of the subjects during the study
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	Up to approximately 6 months.	ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Overall Survival (OS)	Up to 24 months	defined as the time from randomization to death from any cause during the course of the study.
Number of Subjects with treatment-related adverse events (AEs)	Up to 24 months	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.

Trial Locations

Locations (1)

Zhejiang Province Cancer Hospital; 🇨🇳 Hanzhou, Zhejiang, China