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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT04512417
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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

Study Details

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

Key Dates

Start date
Aug 31, 2020
Status verified
Aug 2020
Primary completion
Aug 31, 2021
Completion
Aug 31, 2022

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combined radiotherapy group
  • Experimental: Immunotherapy alone group

Primary Outcome Measure

Progression-free Survival (PFS) per RECIST 1.1 [ Time Frame: Up to 24 months ]

Central Contacts

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