Last reviewed · How we verify
NCT07291401
Radiotherapy Plus CAPOX, and Iparomlimab and Tuvonralimab (QL1706) as Neoadjuvant Therapy for LARC
Phase 2 trial testing lparomlimab and Tuvonralimab Injection and CPAOX and radiotherapy in Rectal Cancer Patients in 108 participants. Not yet recruiting.
1 January 2027
Quick facts
| Lead sponsor | Zhongnan Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 1 January 2026 |
| Primary completion | 1 January 2027 |
| Estimated completion | 1 January 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- lparomlimab and Tuvonralimab Injection and CPAOX and radiotherapy
- CPAOX and radiotherapy
Conditions studied
- Rectal Cancer Patients — all drugs for Rectal Cancer Patients →
Sponsor
Zhongnan Hospital
Who can join
Adults 18 to 75, any sex, with Rectal Cancer Patients. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a single-center, prospective, randomized, double-arm, Phase II clinical trial designed to evaluate the efficacy of radiotherapy combined with CAPOX, and Iparomlimab and Tuvonralimab (QL1706) as neoadjuvant therapy for locally advanced rectal cancer. Additionally, the study seeks to explore the relationship between biomarkers in blood and tumor tissue and treatment efficacy. Eligible participants (locally advanced rectal cancer) were randomly assigned in a 1:1 ratio to two groups. Participants will: Group A patients received radiotherapy, chemotherapy, and immunotherapy. During the first week of radiotherapy, they received one cycle of CAPOX concurrent chemoradiotherapy. Two weeks after the completion of radiotherapy, they continued with four cycles of CAPOX combined with QL1706 immunotherapy. Group B patients received radiotherapy and chemotherapy. After completing the concurrent radiotherapy and chemotherapy, they rested for 2-3 weeks before completing 3 cycles of CAPOX consolidation chemotherapy. Two to three weeks after the completion of neoadjuvant therapy in groups A and B, the efficacy was evaluated, and a decision was made on whether to proceed with surgery or watchful waiting based on the efficacy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07291401
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rectal Cancer Patients
Currently open trials in the same condition.
- NCT07522294 — Optimization and Standardization of Single-Port Robotic Transanal Minimally Invasive Surgery for Rectal Tumor Excision · NA · active not recruiting
- NCT07198165 — SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC · Phase 2 · recruiting
- NCT07337811 — Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Undergo · NA · recruiting
- NCT06647680 — Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01） · Phase 2 · recruiting
- NCT06911684 — Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC · Phase 2 · recruiting
Other Zhongnan Hospital trials
Trials by the same sponsor.
- NCT07515963 — FULIRI Plus Targeted Therapy for First-line Conversion Therapy of Colorectal Cancer Liver Metastases. · Phase 2 · not yet recruiting
- NCT07420036 — An Open-label, Single-arm, Single-center Study to Evaluate the Diagnostic Efficacy of a Novel PET Probe, 68Ga-SFB6-ZN01, · EARLY_PHASE1 · not yet recruiting
- NCT07453966 — Efficacy and Safety of Intrapulmonary Percussive Ventilation in Patients With Pulmonary Infection Receiving Invasive Mec · NA · recruiting
- NCT07363330 — A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer · Phase 2 · not yet recruiting
- NCT07460258 — A Study on the Effect of Medical Students' Literature Reading Patterns on Cognitive Load and Academic Writing Ability · recruiting
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 NCT07291401 (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 Zhongnan Hospital
- Last refreshed: 18 December 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/NCT07291401.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing