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

ConditionLocally Advanced Rectal Cancer (LARC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign a written Informed Consent Form (ICF) and be able to comply with the visits and related procedures stipulated in the protocol

Age between 18 and 75 years old

Histologically confirmed rectal adenocarcinoma

According to the AJCC 8th Edition staging, imaging evaluation (enhanced CT or enhanced MRI) confirms resectable locally advanced rectal cancer (AJCC 8th Edition staging cT3-4 / cN+)

Disqualifiers

Patients with rectal cancer who have been tested for microsatellite instability as MSI-H or mismatch repair as dMMR

Patients who have previously received any anti-tumor treatment for the studied disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. This includes previous treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs, or any other drugs acting on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.), as well as adoptive cell immunotherapy

Simultaneous participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study

Treatment with any investigational drug or device within 4 weeks prior to the first dose of the study drug

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental

    Drug

    The experimental group will receive neoadjuvant short-course radiotherapy (dose 25Gy/5f), followed by CAPEOX+Iparomlimab and Tuvonralimab (capecitabine 1000mg/m2 bid po d1-d14, q3w; oxaliplatin 130mg/m2 iv d1, q3w; Iparomlimab and Tuvonralimab 5mg/kg iv d1, q3w) for 4 cycles. Patients who undergo surgery will receive CAPEOX combined with Iparomlimab and Tuvonralimab for 4 cycles, followed by sequential treatment with Iparomlimab and Tuvonralimab for up to 1 year.

  • Control

    Drug

    The control group will receive neoadjuvant short-course radiotherapy,followed by CAPEOX (capecitabine 1000mg/m2 bid po d1-d14, q3w; oxaliplatin 130mg/m2 iv d1, q3w) for 4 cycles. Patients who undergo sugery will receive CAPEOX for 4 cycles.

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Experimental ArmExperimental treatment 1 intervention
Group B: Control ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

Complete Response

Time frame
From date of randomization until the date of treatment of surgery, assessed up to 5 months
2

Clinical Complete Response

Time frame
From date of randomization until the date of discussion of multidisciplinary team, assessed up to 5 months
3

Pathologic Complete Response

Time frame
From date of randomization until the date of treatment of surgery, assessed up to 5 months

Secondary outcomes

1

Organ Preservation Rate

Time frame
From date of randomization until the date of treatment of additional surgery, assessed up to 100 months
2

Major Pathologic Response

Time frame
From date of randomization until the date of treatment of surgery, assessed up to 5 months
3

Overall Surviral

Time frame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
4

Desease Free Survival

Time frame
From date of randomization until the date of first documented progression, whichever came first, assessed up to 100 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Zhejiang University

Lead sponsor

Ningbo No.2 Hospital

Collaborator

Ningbo Medical Center Lihuili Hospital

Collaborator

Second Affiliated Hospital of Wenzhou Medical University

Collaborator

Ningbo No. 1 Hospital

Collaborator

The Affiliated People's Hospital of Ningbo University

Collaborator

Taizhou Hospital

Collaborator

Source ClinicalTrials.gov
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