2026-04-29
notable
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-03→confirmed 2026-03-23
Study sites1→2
InterventionsAdebrelimab combined with chemotherapy (Drug), Adebrelimab in combination with SHR-8068 and chemotherapy (Drug), chemotherapy (Drug)→Adebrelimab combined with chemotherapy (Drug), Adebrelimab in combination with SHR-8068 and chemotherapy (Drug), Chemotherapy (Drug)
Eligibility criteria-12 characters
[...] o have experienced local recurrence after previous treatment ;.
Patients with concurrent colon tumors ;.
Patients with initially unresectable colorectal cancer as e [...] ion is determined by researchers to be intolerant to surgery ;.
Clinical or imaging examinations suggest the presence of in [...] as having a relatively high risk of perforation or bleeding ;.
With distant metastases;.
Imaging examination of rectal cancer indicated positive lateral lymph nodes ;.
Having received surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. for tumors ;.
Female participants who are pregnant, b [...] [...]
Secondary endpoints8 entries, revised
Phase II：: Clinical complete response (cCR) rate;
Phase II: Disease-free survival (DFS);
Phase II：: EFS（ (Event Free Survival ）;)
Phase II：: Tumor regression grade (TRG);
Phase II：: R0 resection rate;
Phase II：: length of hospital stay;
Phase II：: Overall survival (OS)
Phase II：: Perioperative mortality (within 30 days and 90 days after surgery)
Primary endpoints1 entry, revised
phasePhase II：: pCR（ (Pathological Complete Response）) rate
Study title-71 characters
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study of Adebrelimab in Combination With SHR-8068 [...]