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

NCT06204094 | Recruiting Phase 2 DMC

• 1 other identifier: Jinhua CH
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Rectal Cancer

Keywords

rectal cancer; microsatellite stability; node-sparing; CAPOX; radiotherapy; sintilimab; immunotherapy; neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Complete response

  Pathological complete response (pCR) ：absence of residual tumour on resected specimen. Clinical complete response（cCR）: no residual tumour visible on imaging or colonoscopy and biopsy.

  within 10 days after TNT therapy or surgery

Secondary Outcomes (8)

• Tumor regression grade

  within 10 days after surgery

• Local recurrence rate(LRR)

  3 years after sugery

• Disease free survival(DFS)

  3 years after treatment

• Overall survival(OS)

  3 years after enrollment

• Adverse effects rate

  From date of initiation of treatment until the date of death from any cause, assessed up to 5 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Participants will receive 5\*5Gy node-sparing short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with total neoadjuvant CAPOX and sintilimab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and sintilimab, 200mg intravenous infusion d1 of each cycle. CAPOX and sintilimab are repeated every 3 weeks for 6 cycles. Patients with cCR will be managed with a WW strategy, and patients who did not achieve cCR will receive TME surgery. Interventions: * Radiation: node-sparing short-course radiation * Drug: PD-1 antibody (Sintilimab) * Drug: Capecitabine * Drug: Oxaliplatin

Radiation: node-sparing short-course radiotherapy; Drug: Sintilimab; Drug: Capecitabine; Drug: Oxaliplatin; Procedure: TME surgery; Procedure: watch and wait

Interventions

Sintilimab DRUG

200mg intravenous infusion d1 of each cycle\*6cycles

Also known as: IBI308

Treatment Arm

Capecitabine DRUG

1000mg/m2, PO, BID, d1-14 of each cycle\*6cycles

Treatment Arm

Oxaliplatin DRUG

130mg/m2, intravenous infusion,d1 of each cycle\*6cycles

Treatment Arm

TME surgery PROCEDURE

laparoscopic or robotic TME surgery for non-cCR patients

Also known as: total mesorectal excision

Treatment Arm

watch and wait PROCEDURE

WW for cCR patients

Also known as: WW

Treatment Arm

node-sparing short-course radiotherapy RADIATION

5Gy\*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/cT3-4N0/+M0, the lymph nodes are limited to the mesorectum.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinhua Central Hospital: lead

Study Sites (1)

Zhejiang University Affiliated Jinhua Hospital

Jinhua, Zhejiang, 0579, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

sintilimab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Central Study Contacts

jinlin du, master

CONTACT

86 13957998111; djl9090@163.com

cheng cai, master

CONTACT

86 18395995912; ColoSurg_cc@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Radiation: node-sparing short-course radiotherapy (5Gy\*5d) Drug: PD-1 antibody (Sintilimab) Drug: Capecitabine Drug: Oxaliplatin

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: inhuaCH will consider access to study data upon a written detailed request sent to JinhuaCH, from 6 months until 5 years after publication of summary data.
• Access Criteria: The data shared will be limited to that required for independent mandated verification of the published results, the applicant will need authorization from JinhuaCH for personal access, and the data will only be transferred after signing of a data access agreement.

Locations

CN (1)