SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShandong Provincial Hospital

About this trial

This is a multicenter, cohort, prospective study to evaluate the efficacy and safety of Adebrelimab combined with radiotherapy and chemotherapy as preoperative neoadjuvant therapy for patients with locally advanced rectal cancer. In the study, all subjects who meet the inclusion criteria will enter the short-term radiotherapy queue and the long-term radiotherapy queue at the ratio of 1:1. The short-term radiotherapy queue plans to receive Adebrelimab combined with short-term radiotherapy (5\*5Gy) and Capox chemotherapy as neoadjuvant therapy. The long-term radiotherapy queue plans to receive Adebrelimab combined with long-term radiotherapy (1.8gy × 25-28 times) and capox chemotherapy as neoadjuvant therapy. The TME surgery will be performed 2-3 weeks after the last neoadjuvant therapy is completed. If the surgery cannot be performed within the time window specified in the plan (such as delayed adverse reactions, etc.), the researcher will conduct the surgery according to the patients' requirements.The actual clinical conditions of the subjects were comprehensively considered.

Eligibility criteria

Qualifiers

1. sign written informed consent before implementing any test related process;

2. Patients diagnosed as rectal adenocarcinoma by primary biopsy and histopathological examination;

3. patients with CT stage ≥ T3 or CN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (>5mm) who are judged by imaging and colonoscopy to be operable and need neoadjuvant therapy.

4. according to imaging and colonoscopy, the main body of the tumor was located ≤ 10cm from the anal edge;

Disqualifiers

1. patients diagnosed with other malignant tumors and not cured within 5 years before the first administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or cancer in situ after radical resection);

2. Patients with advanced rectal cancer with distant metastasis;

3. currently participating in intervention clinical research treatment, or having received other research drugs or used research instruments within 4 weeks before the first administration;

4. have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);

Trial design

Treatments tested in this trial

  • short-term radiotherapy combined with Adebrelimab and capox
  • long-term radiotherapy combined with Adebrelimab and capox

Treatment groups

208 Participants
are divided into 2 treatment groups

Sponsors and collaborators