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NCT07026422
Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT)
Phase 2 trial testing Total neoadjuvant therapy integrating iparomlimab/tuvonralimab with chemoradiotherapy in Rectal Malignant Neoplasms in 54 participants. Currently enrolling.
30 November 2026
Quick facts
| Lead sponsor | Shandong Cancer Hospital and Institute |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 30 May 2025 |
| Primary completion | 30 November 2026 |
| Estimated completion | 30 May 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Total neoadjuvant therapy integrating iparomlimab/tuvonralimab with chemoradiotherapy
Conditions studied
- Rectal Malignant Neoplasms — all drugs for Rectal Malignant Neoplasms →
Sponsor
Shandong Cancer Hospital and Institute
Who can join
Adults 18 to 75, any sex, with Rectal Malignant Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07026422 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shandong Cancer Hospital and Institute
- Last refreshed: 18 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07026422.
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