Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06864013

SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer

Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-01-14

116

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

N

Ningbo No.2 Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Colorectal cancer ranks as the third most prevalent malignancy worldwide and the second leading cause of cancer-related mortality. For patients with locally advanced rectal cancer (LARC) classified as T3-4/N+ without distant metastasis, achieving organ preservation and functional integrity while pursuing curative treatment remains a formidable clinical challenge. This study aims to evaluate the efficacy and organ preservation rates of a novel neoadjuvant regimen comprising short-course radiotherapy followed by four cycles of CAPEOX combined with Iparomlimab and Tuvonralimab in patients with microsatellite stable (MSS) or mismatch repair proficient (pMMR) LARC. Furthermore, the project will investigate potential predictive biomarkers for complete response (CR) within this immunotherapy-based total neoadjuvant therapy (iTNT) paradigm.

CONDITIONS

Official Title

SCRT Combined With Chemotherapy and Iparomlimab and Tuvonralimab in MSS or pMMR Patients With Locally Advanced Rectal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent and able to follow study visits and procedures
  • Age between 18 and 75 years
  • Histologically confirmed rectal adenocarcinoma
  • Resectable locally advanced rectal cancer (stage cT3-4 / cN+) per AJCC 8th Edition imaging
  • Microsatellite stable (MSS) or mismatch repair proficient (pMMR) rectal cancer
  • At least one lesion measurable by RECIST v1.1 criteria
  • ECOG performance status score of 0 to 1
  • Adequate organ and bone marrow function, including specified blood counts, liver and kidney function, and coagulation
  • No serious diseases expected to limit survival to less than 5 years
  • Effective contraception used during treatment and for 6 months after in subjects of childbearing potential
Not Eligible

You will not qualify if you...

  • Rectal cancer with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR)
  • Prior anti-tumor treatment for the disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
  • Participation in another interventional clinical study (except observational or survival follow-up studies)
  • Treatment with investigational drugs or devices within 4 weeks before first study dose
  • Recent blood transfusion or use of certain growth factors before screening
  • Use of immunosuppressive drugs within 4 weeks before first study dose, with some exceptions
  • Receipt of live or attenuated vaccines within 4 weeks before first study dose or expected during study
  • Major surgery within 4 weeks before first study dose, or presence of unhealed wounds
  • Active or recent autoimmune disease, except for some stable conditions
  • History of primary immunodeficiency
  • Active tuberculosis or recent anti-tuberculosis treatment
  • History of organ transplantation
  • Allergy to study drugs or related monoclonal antibodies
  • Significant fluid accumulations requiring intervention
  • HIV infection
  • Active hepatitis B or C infection
  • Active syphilis requiring treatment
  • Severe or recent infections
  • Heart failure, uncontrolled arrhythmia, or certain heart conditions
  • Uncontrolled high blood pressure
  • Severe bleeding or clotting disorders
  • Recent serious thromboembolic events
  • Esophageal or gastric varices needing intervention or high bleeding risk
  • Recent gastrointestinal perforation or fistula
  • Recent life-threatening bleeding
  • Recent serious thromboembolic events
  • Uncontrolled metabolic or systemic diseases
  • Severe liver disease
  • Intestinal obstruction or related severe bowel conditions
  • Interstitial lung disease or severe lung impairment
  • Significant malnutrition or need for intravenous nutrition
  • History of other cancers unless cured with no active disease for 2 years
  • Other acute or chronic diseases increasing study risk or interfering with results
  • Neurological, psychiatric, or social issues affecting compliance or consent
  • Alcohol, drug, or substance use impacting treatment or safety
  • Pregnancy or breastfeeding
  • Any other condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

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Research Team

G

Guosheng Wu, MD

CONTACT

W

Weiqin Jiang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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