Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer

Sponsor
The First Affiliated Hospital of Zhengzhou University
Study ID
NCT06760520
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Rectal Cancer

Eligibility Criteria

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

Interventions

  • Ivonescimab (SMT112 or AK112) Injection — DRUG
    Eligible subjects will receive short-course radiotherapy (SCRT), 25Gy/5f/1 week. 1-2 weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 850-1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).

Study Details

This study is a single-arm, prospective, phase II clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with ivonescimab and chemotherapy + total mesorectal excision(TME) surgery in patients with advanced rectal cancer.

Key Dates

Start date
Jan 20, 2025
Status verified
Dec 2024
Primary completion
Dec 20, 2027
Completion
Dec 20, 2031

Study Design

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

Arms

  • Experimental: ivonescimab+chemotherapy
    Local advanced rectal cancer with short-course radiotherapy followed by sequential chemotherapy and ivonescimab

Primary Outcome Measure

Complete response rate (CR, pCR plus cCR ) [ Time Frame: pCR rate : within 1 week after surgery；cCR：12-13 weeks after radiotherapy ends ]

Central Contacts

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