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

NCT ID: NCT04512417

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2022-08-31

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Combined radiotherapy group

Group Type: EXPERIMENTAL

Camrelizumab+Radiotherapy

Intervention Type: 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.

Immunotherapy alone group

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

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

Interventions

Camrelizumab+Radiotherapy

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.

Intervention Type: DRUG

Camrelizumab

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

Intervention Type: DRUG

Other Intervention Names

SBRT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Province Cancer Hospital

Hanzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Ming, MD

Role: CONTACT

chenming@zjcc.org.cn

0571-88122199

Facility Contacts

Chen Ming, MD

Role: primary

chenming@zjcc.org.cn

0571-88122199

Other Identifiers

IRB-2020-176

Identifier Type: -

Identifier Source: org_study_id