Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for … (NCT05794750) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC(AK104-IIT-13)
50 participantsStarted 2023-04-24
Plain-language summary
This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with AK104 and chemotherapy + 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:
* 1\. Age 18-75 years old, gender is not limited;
* 2\. Stage II/III under MRI or endoscopic ultrasound ;
* 3\. Fiber colonoscopy or diagnosis examination, the lower boundary of the lesion is 15m ≤ from the margin;
* 4\. Rectal adenocarcinoma confirmed or revisited by pathology;
* 5\. Karl Fischer score ≥ 80 points or ECOG score of 0-1;
* 6\. Meet the following laboratory diagnostic indicators: hemoglobin ≥ 100g/L, white blood cell ≥ 3.5×109/L; neutrophils≥ 1.5×109/L, platelet ≥ 100×109/L; creatinine ≤ 1.0× upper limit of normal (UNL), urea nitrogen (BUN) ≤ 1.0× upper limit of normal (UNL); Alanine aminotransferase (ALT) ≤1.5× upper limit of normal (UNL); Aspartate aminotransferase (AST) ≤1.5× upper limit of normal (UNL); Alkaline phosphatase (ALP) ≤1.5× upper limit of normal (UNL); Total bilirubin (TBIL) ≤ 1.5× upper limit of normal (UNL); urine protein (-); Clotting time is normal.
* 7\. No history of allergy to 5-Fu drugs, no history of allergy to platinum drugs;
* 8\. With primary rectal cancer required to undergo surgery (except palliative ostomy), chemotherapy or other anti-tumor therapy before diagnosis to enrollment;
* 9\. Not received radiation before;
* 10\. Sign the informed consent form.
Exclusion Criteria:
* 1\. Previous anti-PD-1/L1 and anti-CTLA-4 immune drugs or other immunoassay drugs;
* 2\. With severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroder…
What they're measuring
1
Pathologic complete response rate (pCR)
Timeframe: From date of randomization until the date of end of treatment,about 18 weeks.