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Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06204094•Jinhua Central Hospital

View on ClinicalTrials.gov

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.

Detailed Description

This is an open-label, prospective, single-center phase II clinical trial to evaluate node-sparing short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with total neoadjuvant CAPOX and PD-1 Inhibitor (Sintilimab) for patients with MSS locally advanced of middle and low rectal cancer. A total of 47 patients will be enrolled in this trial. The primary endpoint is the complete response(CR) rate, which includes cCR and pCR. The organ preservation rate, tumor regression grade, 3-year DFS, 3-year OS, and adverse effects will also be analyzed.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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.
+3 more criteria

Locations (1)

Zhejiang University Affiliated Jinhua Hospital

Jinhua, Zhejiang, China

Key Dates

Start Date

February 5, 2024

Primary Completion Date

September 1, 2027

Completion Date

September 1, 2028

Last Updated

January 7, 2025

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Rectal Cancer

Interventions

node-sparing short-course radiotherapy

RADIATION

Sintilimab

DRUG

Capecitabine

DRUG

Oxaliplatin

DRUG

TME surgery

PROCEDURE

watch and wait

PROCEDURE

Contacts

jinlin du, master

CONTACT

86 13957998111 djl9090@163.com

cheng cai, master

CONTACT

86 18395995912 ColoSurg_cc@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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