Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer (NCT06760520) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer
40 participantsStarted 2025-01-20
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ECOG score of 0-1;
* histologically or cytologically confirmed colorectal adenocarcinoma with non-distant metastasis
* Tumor distance from anal verge ≦10cm
* at least one high-risk criterion defined by pelvic MRI: cT stage \>T2 (tumor invades intrinsic muscularis propria by more than 5 mm); Extramural vascular invasion; cN2; Involvement of the rectal mesorectal fascia (tumor or lymph node ≤1mm from the rectal mesorectal fascia); Lateral lymph node short diameter ≥5mm
* enough organ function
Exclusion Criteria:
* with known MSI-H or dMMR
* Multiple primary adenocarcinomas
* History of pelvic radiotherapy
* Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immunocellular therapy, and other treatments targeting the immune mechanism of the tumor.
What they're measuring
1
Complete response rate (CR, pCR plus cCR )
Timeframe: pCR rate : within 1 week after surgery;cCR:12-13 weeks after radiotherapy ends
Trial details
NCT IDNCT06760520
SponsorThe First Affiliated Hospital of Zhengzhou University