Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT07057089
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine — DRUG
    Capecitabine: 825mg/m2, bid;
  • Camrelizumab — DRUG
    Camrelizumab: 200mg
  • CAPOX — DRUG
    CAPOX
  • Involve-field irradiation — RADIATION
    Involve-field irradiation: Primary rectal tumor + metastatic or suspicious pelvic lymph nodes, mesorectal region, and presacral region
  • Elective nodal irradiation — RADIATION
    Elective nodal irradiation: Large pelvic field
  • TME surgery — PROCEDURE
    TME surgery

Study Details

The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.

Key Dates

Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Mar 1, 2028
Completion
Dec 1, 2030

Study Design

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

Arms

  • Experimental: Involve-field radiotherapy-TNT+Camrelizumab
    Patients received Involve-field radiotherapy (25Gy/5f, including the primary rectal tumor, metastatic or suspected pelvic lymph nodes, mesorectal, and presacral regions). Four cycles of CAPOX plus Carilizumab were given to patients 1-2 weeks after chemoradiotherapy completion. Patients were evaluated 2-3 weeks after the end of treatment. Patients who met the cCR criteria could choose to undergo surgical treatment or not. For patients who did not meet the cCR criteria, surgical treatment was recommended. For patients who refused surgery, the patients in the trial group continued to receive 4 cycles of CAPOX chemotherapy combined with camrelizumab.
  • Other: Elective nodal irradiation-TNT
    Patients received elective nodal long-course concurrent chemoradiotherapy (50.4 Gy/28f). Capecitabine (825 mg/m² bid) was administered orally on radiotherapy days. Four cycles of CAPOX were given to patients 1-2 weeks after chemoradiotherapy completion. Patients were evaluated 2-3 weeks after the end of treatment. Patients who met the cCR criteria could choose to undergo surgical treatment or not. For patients who did not meet the cCR criteria, surgical treatment was recommended. For patients who refused surgery, the patients in the trial group continued to receive 4 cycles of CAPOX chemotherapy.

Primary Outcome Measure

CR rate [ Time Frame: within 5 weeks ]

Central Contacts

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