Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT06802666
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Rectal Cancer
  • Neoadjuvant Therapy

Eligibility Criteria

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

Interventions

  • short-course radiotherapy — RADIATION
    Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with AK112 regimen for 6 cycles.
  • Ivonescimab — DRUG
    AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W)
  • capecitabine — DRUG
    1000mg/m2, bid, po, d1-14,q3w
  • oxaliplatin — DRUG
    130mg/m2, ivgtt, d1,q3w
  • TME surgery — PROCEDURE
    The surgery was performed 1 week after the end of neoadjuvant therapy.

Study Details

This study aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with locally advanced rectal cancer

Key Dates

Start date
Oct 16, 2024
Status verified
Jan 2025
Primary completion
Sep 1, 2026
Completion
Dec 30, 2027

Study Design

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

Arms

  • Experimental: SCRT+AK112+chemotherapy
    short-course radiotherapy followed by sequential chemotherapy and AK112

Primary Outcome Measure

Pathologic complete response rate (pCR) [ Time Frame: though 19 weeks neoadjuvant treatment，after surgery completed ]

Central Contacts

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