Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab

Sponsor
Harbin Medical University
Study ID
NCT06304545
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    Camrelizumab IV 200mg
  • Chemotherapy — DRUG
    Capecitabine PO oxaliplatin IV
  • Radiotherapy — RADIATION
    Radiotherapy 50Gy /45Gy /25 fractions

Study Details

This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation.

Key Dates

Start date
Mar 15, 2024
Status verified
Mar 2024
Primary completion
Aug 16, 2026
Completion
Mar 15, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemoradiotherapy combined with immunotherapy for early rectal cancer.
    Radiotherapy and Chemotherapy combined with Camrelizumab

Primary Outcome Measure

Pathological Complete Response rate [ Time Frame: up to 24 months ]

Central Contacts

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