SIB-RT Combined With CAPOX and PD-1 for High-Risk Rectal Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT07297030
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

  • SIB-SCRT — RADIATION
    The pelvic lymphatic drainage regions receive 25 Gy in 5 fractions (5 Gy per fraction). A ssequential boost to a total dose of 30 Gy in 6 fractions is delivered to the primary tumour and any radiologically suspicious lymph nodes.
  • CAPOX — DRUG
    * Oxaliplatin 130 mg/m² intravenously on day 1. * Capecitabine 1,000 mg/m² orally twice daily on days 1-14.
  • Immunotherapy — DRUG
    \- Tislelizumab 200 mg intravenously on day 1.

Study Details

The biological effective dose of short-course radiotherapy is relatively lower compared to long-course radiotherapy, which may lead to an increased local recurrence rate in patients with mid to low rectal cancer who are at high risk of locally advanced disease due to insufficient radiation dose. Combining short-course radiotherapy with simultaneous integrated boost (SIB) and immunotherapy-chemo regimens could potentially further enhance tumor regression and improve local control, providing a promising treatment option for high-risk locally advanced rectal cancer patients. Therefore, this clinical trial aims to explore the safety and effectiveness of a short-course SIB radiotherapy regimen combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced rectal cancer, based on short-course radiotherapy combined with chemotherapy and immunotherapy.

Key Dates

First listed
Dec 22, 2025
Start date
Dec 20, 2025
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
May 1, 2029

Study Design

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

Arms

  • Experimental: SIB-SCRT+CAPOX+PD-1
    Patients received neoadjuvant treatment consisting of SIB-SCRT ( PTV-GTV 31Gy/5F/6.2Gy) followed by sintilimab (3mg/kg intravenous drip on day 1; every 3-week cycle for two cycles) combined with CAPOX (oxaliplatin 130 mg/m2 intravenous infusion over 2 h on day 1, capecitabine 1000 mg/m2 orally twice daily from day 1-14, in every 3-week cycle for two cycles) 1 week later.

Primary Outcome Measure

The Complete Response (CR) rate [ Time Frame: 3 months ]

Central Contacts

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