RecruitingPhase 2NCT06204094

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Total Neoadjuvant CAPOX and PD-1 Inhibitor（Sintilimab） Combined with Node-sparing Short-course Radiotherapy for MSS Locally Advanced of Middle and Low Rectal Cancer(CASINOs): an Open Label, Single-arm, Prospective Clinical Trial

Sponsor

Jinhua Central Hospital

Enrollment

37 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Rectal Cancer

Summary

phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
Male or Female aged 18-75.
Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT2N+M0/cT3-4aN0/+M0, the lymph nodes are limited to the mesorectum, the circumferential resection margin is negative.
Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
Eastern Cooperative Oncology Group (ECOG) 0-1.
No previous treatment(including anti-tumor therapy、immunotherapy or pelvic radiation).
Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood cells ≥3500/mm3, neutrophils ≥1800/mm3, platelets ≥100,000/mm3, hemoglobin ≥100 g/L; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g/L. creatinine clearance ≥50 mL/mi, creatinine ≤1.5 × ULN;
Informed consent form signed.

Exclusion Criteria13

Patients with a previous history of malignant tumors besides rectal cancer.
Patients with distant metastases before enrollment.
Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT.
Patients with obstruction, perforation, or bleeding that require emergency surgery.
Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
Allergic to any component of the therapy.
Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous adenocarcinoma.
Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.
Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities.
Patients with congenital or acquired immune deficiency (such as HIV infection).
Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.
Other conditions that investigators consider not suitable for this study.