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

NCT04512417 | Unknown Phase 2 DMC

• 1 other identifier: IRB-2020-176
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; Camrelizumab; IO、Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) per RECIST 1.1

  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.

  Up to 24 months

Secondary Outcomes (4)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  Up to approximately 6 months.

• Overall Survival (OS)

  Up to 24 months

• Number of Subjects with treatment-related adverse events (AEs)

  Up to 24 months

• Failure mode

  Up to 24 months

Study Arms (2)

Combined radiotherapy group

EXPERIMENTAL

Drug: Camrelizumab+Radiotherapy

Immunotherapy alone group

EXPERIMENTAL

Drug: Camrelizumab

Interventions

Camrelizumab+Radiotherapy DRUG

The combined treatment group received radiotherapy for recurring or metastatic lesions: at least one or more lesions were irradiated, stereotactic body radiotherapy (SBRT, 8Gy/time, 3-5 times) or conventional radiotherapy (parts not suitable for SBRT, total Dose 30Gy or more); start immunotherapy within 8 weeks after radiotherapy.Until PD or toxicity is intolerable or up to 24 months.

Also known as: SBRT

Combined radiotherapy group

Camrelizumab DRUG

Camrelizumab,200mg,Q3W,Until PD or toxicity is intolerable or up to 24 months.

Immunotherapy alone group

Eligibility Criteria

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

You may qualify if:

• \. 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;
• \. Recurrent or metastatic esophageal cancer confirmed by histology or cytology, patients with ≤4 metastatic lesions;
• \. Progress after first-line chemotherapy;
• \. There are lesions measurable according to RECIST standards
• \. Age ≥18 years old and ≤75 years old, regardless of gender
• \. ECOG physical strength status score is 0～2;
• \. Have not received immunotherapy or biological therapy before;
• \. Hemoglobin ≥90g/L, platelets ≥10×109/L, absolute neutrophil count ≥1.5×109/L;
• \. Serum creatinine ≤1.25 times UNL or creatinine clearance ≥60 mL/min;
• \. Serum bilirubin≤1.5×UNL, AST (SGOT) and ALT (SGPT)≤2.5×UNL, alkaline phosphatase≤5×UNL;
• \. No history of interstitial pneumonia or previous interstitial pneumonia;

You may not qualify if:

• \. 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;
• \. Have received radiotherapy in the past, and the tumor in the irradiation field has progressed;
• \. Metastasis of meninges, pleura or pericardium;
• \. Esophageal perforation and active esophageal bleeding, with invasion of trachea and large blood vessels in the thoracic cavity;
• \. Patients with severe cardiovascular or pulmonary diseases, interstitial pneumonia or previous history of interstitial pneumonia:
• \. Patients who cannot understand the test requirements or may not comply with the test requirements;
• \. 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);
• \. Active hepatitis B or C that requires treatment;
• \. Suffered from an active infection requiring systemic treatment 14 days before the first administration;
• \. Patients with other malignant lesions, except for curable skin cancer (non-melanoma), cervical carcinoma in situ or malignant disease cured ≥5 years;
• \. The researcher believes that some obvious diseases should be excluded from this research;
• \. The dose limit of radiotherapy cannot meet the limit requirement set by this study.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Province Cancer Hospital

Hanzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Chen Ming, MD

CONTACT

0571-88122199; chenming@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 13, 2020
• Study Start: August 31, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2022
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

CN (1)