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

J

Jinhua Central Hospital

Status and phase

Not yet enrolling
Phase 2

Conditions

Locally Advanced Rectal Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06204094
Jinhua CH

Details and patient eligibility

About

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

Full 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.

Enrollment

37 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

37 participants in 1 patient group

Treatment Arm
Experimental group
Description:
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 8 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
Treatment:
Drug: Capecitabine
Procedure: watch and wait
Radiation: node-sparing short-course radiotherapy
Drug: Oxaliplatin
Drug: Sintilimab
Procedure: TME surgery

Trial contacts and locations

1

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Central trial contact

cheng cai, master; jinlin du, master

Data sourced from clinicaltrials.gov

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