Actively Recruiting
Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT)
Led by Shandong Cancer Hospital and Institute · Updated on 2025-06-18
54
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In colorectal cancer (CRC), ICIs show strong therapeutic associations with microsatellite instability-high (MSI-H) status, while patients with proficient mismatch repair/microsatellite stable (pMMR/MSS) tumors exhibit poor responses. Dual immunotherapy may represent a promising strategy for MSS populations. The Dutch NICHE trial reported a 27% pathological response rate (4/15) in MSS CRC patients with clinical stage I-III disease treated with neoadjuvant ipilimumab plus nivolumab. In advanced or metastatic CRC, a study by Jin Li et al. demonstrated that iparomlimab/tuvonralimab combined with bevacizumab and the XELOX regimen achieved an objective response rate of 70.6% (95% CI: 56.2%-82.5%). Radiotherapy may synergize with ICIs through multiple immunomodulatory mechanisms. For pMMR/MSS LARC, combining CRT with ICIs holds promise to overcome the "immune-cold" tumor microenvironment and improve therapeutic efficacy. In this clinical trial, the investigators aim to evaluate the efficacy and safety of integrating immunotherapy with CRT as a novel total neoadjuvant therapy for pMMR/MSS rectal cancer.
CONDITIONS
Official Title
Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Histologically confirmed pMMR/MSS rectal adenocarcinoma at clinical stage II (T3-4, N-) or III (any T, N+)
- Tumor located within 12 cm of the anal verge with at least one high-risk factor: cT4, cN2, extramural vascular invasion, mesorectal fascia involvement, lateral lymph node involvement, tumor deposit, or low rectal cancer (≤5 cm from anal verge)
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- No distant metastases based on chest and abdominal CT or whole body PET-CT
- No other types of rectal cancer or synchronous colon cancer
- Presence of measurable lesions meeting RECIST v1.1 criteria for evaluation
You will not qualify if you...
- Patients with deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) status
- Myelosuppression without clear cause
- Locally advanced rectal cancer without any high-risk features
- Prior or current other malignancies except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Severe allergic reactions to other monoclonal antibodies
- Uncontrolled cardiac symptoms or disease
- Active autoimmune diseases, immunodeficiencies, organ transplantation history, or systemic immunosuppressive therapy
- Abnormal blood clotting, bleeding tendencies, or on blood thinning treatments
- History or evidence of lung diseases such as pulmonary fibrosis, pneumonitis, or severely impaired lung function
- Previous antitumor therapies including radiotherapy, chemotherapy, immune checkpoint inhibitors, or T-cell therapies
- Known HIV infection, active syphilis, tuberculosis, or hepatitis B or C infection at screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
J
Jinbo Yue, Docter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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