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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
short-term radiotherapy combined with Adebrelimab and capox
Combination productRadiotherapy protocol: 5 × 5Gy short-term radiotherapy (D1-5 in the first week) Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle. Chemotherapy regimen: capox regimen: Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ～ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme.
long-term radiotherapy combined with Adebrelimab and capox
Combination productRadiotherapy regimen: long-term radiotherapy 1.8 × 25-28Gy, oral capecitabine in the same period: the standard dose is 825mg/m2, twice a day \[total dose 1650mg/(M2 · d)\], oral radiotherapy day, 5 days a week. Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle. Chemotherapy regimen: capox regimen: Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ～ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme.
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CR rate
pathological complete remission rate (PCR) and clinical complete remission rate (CCR)
Time frame
From enrollment to the end of surgery,assessed up to 6 monthsSecondary outcomes
1
partial remission rate (PR)
the total diameter of all measurable target lesions is ≥ 30% lower than the baseline
Time frame
The evaluation time from enrollment to the first efficacy evaluation is up to 3 months2
Objective response rate (ORR)
Proportion of subjects defined as complete remission (CR) and partial remission (PR) in total subjects
Time frame
The evaluation time from enrollment to the first efficacy evaluation is up to 3 months3
Major Pathological Response Rate (MPR)
Major Pathological Response Rate (MPR)
Time frame
From enrollment to the end of surgery,assessed up to 6 months4
R0 resection rate
There is no visible tumor residue in the body, and no residual tumor cells are found under the pathological microscope
Time frame
From enrollment to the end of surgery,assessed up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov