Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer

Sponsor
Changhai Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05215379
Collaborator
(none)
180
1
2
32
5.6

Study Details

Study Description

Brief Summary

At present, there are no relevant studies or reports on the effect of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer. Studied in this paper combin neoadjuvant chemoradiation with immune therapy, carry out "Multicenter prospective randomized clinical trial of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer" in order to provide a high-level evidence-based medical evidence for ultra-low rectal cancer treatment and improve ultra-low rectal cancer diagnosis and treatment effect.

Condition or Disease Intervention/Treatment Phase
  • Drug: xintilimab injection
  • Other: Control
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicenter Prospective Randomized Clinical Trial of Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: neoadjuvant chemoradiation therapy

neoadjuvant chemoradiation therapy

Other: Control
neoadjuvant chemoradiation therapy

Experimental: neoadjuvant chemoradiation therapy +immunotherapy

neoadjuvant chemoradiation therapy +immunotherapy

Drug: xintilimab injection
neoadjuvant chemoradiation therapy +xintilimab injection 200mg/3week 4cycle

Outcome Measures

Primary Outcome Measures

  1. The rate of cCR [6 months]

    Rate of patients who achieve clinical complete response

Secondary Outcome Measures

  1. The rate of organ preservation [6 months]

    Rate of patients who achieve organ preservation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Ultra low rectal cancer patients evaluated by multidisciplinary team to perform APR

  • Patients who have a strong desire to preserve the anus and are willing to accept neoadjuvant treatment

  • 18 years old ≤ age ≤ 75 years old, no gender limit;

  • Colonoscopy, intracavitary ultrasound and pelvic high-resolution MRI (or enhanced CT) were diagnosed as extremely low rectal cancer within 5 cm from the lower edge of the tumor to the anal edge. The baseline clinical stage is T1-3aN0-1M0, and the size of the tumor <1/2 circle;

  • Histopathological diagnosis of rectal adenocarcinoma; tumor biopsy immunohistochemistry showed pMMR, that is, MSH1, MSH2, MSH6 and PMS2 four proteins are positive, or genetic testing suggests MSI-L or MSS.

  • The patient has good compliance and can come to the hospital for reexamination as required;

  • ECOG physical status score 0-1 points;

  • Have not received anti-tumor and immunotherapy before being selected;

    1. Laboratory inspections must meet the following standards: i. White blood cell count ≥3.5×109/L, absolute neutrophil count ≥1.8×109/L, platelet count ≥100×10^9/L, hemoglobin ≥100g/L; ii. INR≤1.5, and APTT≤1.5 times the upper limit of normal value or partial prothrombin time (PTT)≤1.5 times the upper limit of normal value; iii. Total bilirubin≤1.25 times the upper limit of normal; ALT and AST≤5 times the upper limit of normal; iv. 24h creatinine clearance rate ≥50mL/min or blood creatinine ≤1.5 times the upper limit of normal.
  • Voluntarily sign the informed consent form;

Exclusion Criteria:
  • History of other malignant diseases in the past 5 years;

  • Patients with metastases ;

  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;

  • Those who are known to be allergic to capecitabine, oxaliplatin, PD-1 monoclonal antibody and other drugs;

  • Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, and mucinous adenocarcinoma;

  • The patient is accompanied by any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, hypertension that cannot be controlled by drugs, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardium Infarction, congestive heart failure, severe arrhythmia requiring medication, liver, kidney or metabolic diseases; diseases that affect the life of the patient.

  • The patient's accompanying diseases (such as mental illness, etc.) or conditions (such as alcohol or drug abuse, etc.) will increase the patient's risk of receiving experimental drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results;

  • Within 30 days before screening, the patient has received any other experimental drug treatment or participated in another interventional clinical trial;

  • Women who are pregnant or breastfeeding or who intend to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures;

  • The investigator judges that the patient is not suitable to participate in other situations such as the clinical trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Colorectal Surgery in Changhai Hospital Shanghai Shanghai China 200433

Sponsors and Collaborators

  • Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wei Zhang, Chief physician, professor, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT05215379
Other Study ID Numbers:
  • CHCRS-Immunity
First Posted:
Jan 31, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022