Clinical Study on the Safety and Relationship of Sintilimab Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Not Applicable
Active, not recruiting
- Conditions
- Objective Response Rate for Neoadjuvant Chemotherapy, ORR
- Interventions
- Biological: Sintilimab combined with XELOX
- Registration Number
- NCT07127497
- Brief Summary
This study is designed as a single-center, phase II exploratory clinical trial to evaluate the pathological response rate and safety of sintilimab (PD-1 inhibitor) combined with XELOX regimen (oxaliplatin + capecitabine) for neoadjuvant treatment of LARC. The study focuses on the pMMR/MSS patient population and attempts to provide a new treatment option for patients who cannot tolerate radiotherapy or need to preserve organ function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Pathologically confirmed rectal adenocarcinoma (non-special type and special type, including mucinous adenocarcinoma, signet ring cell carcinoma, serrated adenocarcinoma, micropapillary carcinoma, medullary carcinoma, cribriform comedo adenocarcinoma); preoperative imaging confirmed that the stage is 1) rectal cancer T3 and (or) N+ resectable rectal cancer patients; 2) for T4 patients, re-evaluation of resectability must be conducted after the completion of neoadjuvant therapy, and radiotherapy may be used in combination depending on the situation. 2. Age ≥ 18 years old, gender is not limited, ECOG score 0-2 points; 3. Physical condition and organ function allow for major abdominal surgery/4. Agree that the researchers use blood, stool and pathological sections for research during the study; 5. Major organ function meets the following requirements (laboratory test values within 7 days before enrollment must meet the following standards) ① Routine blood examination: (no blood transfusion, no use of granulocyte colony stimulating factor, no use of drug correction within 14 days before screening): a) Neutrophil ≥ 1.5×109/L; b) Platelet ≥ 75×109/L; c) Hemoglobin ≥ 90g/L; ② Biochemical examination: (no albumin transfusion within 14 days before screening): a) Serum creatinine ≤ 1.5×upper limit of normal (ULN), or creatinine clearance> 50 mL/min; b) Serum total bilirubin ≤ 1.5×ULN; c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; ③ Coagulation function: a) International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeds the normal control range ≤ 6 seconds. 6. Patients are recruited regardless of their programmed death ligand 1 (PD-L1) expression level. -
Exclusion Criteria
- The tumor has distant metastasis or peritoneal metastasis confirmed by laparoscopy; 2) Patients with other severe immunosuppressive diseases or other malignant tumors; 3) Any condition that affects the intestinal absorption of capecitabine; 4) Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases; severe mental illness; severe respiratory diseases; severe liver and kidney dysfunction; history of unstable angina or myocardial infarction within 6 months; history of cerebral infarction or cerebral hemorrhage within 6 months; continuous use of glucocorticoids within 1 month (except local application); 5) The researcher determines that the patient has other complications that endanger the patient's safety or may affect the completion of the study; 6) Currently or previously received other research drugs or any immunotherapy; 7) Suffering from malignant tumors in other parts within five years; 8) The patient is pregnant or lactating;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab c Sintilimab combined with XELOX Sintilimab (3 mg/kg, IV, qd for patients with body weight \< 60 kg; 200 mg, IV, qd for patients with body weight ≥ 60 kg) combined with XELOX (oxaliplatin 130 mg/m2, IV, qd + capecitabine 1000 mg/m2, bid, d1 - d14, q21d) for 2-4 courses
- Primary Outcome Measures
Name Time Method An exploratory, phase II clinical study on the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab combined with chemotherapy From enrollment to 2-4 courses (about 4-8 weeks) of adjuvant therapy Objective response rate refers to the proportion of patients who achieve complete response (CR) and partial response (PR) among the treated patients within a certain period of time.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, An Hui, China
The First Affiliated Hospital of Anhui Medical University🇨🇳Hefei, An Hui, China