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NCT07198165
SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC
Phase 2 trial testing PD-1 inhibitor based immunotherapy in Rectal Cancer in 104 participants. Currently enrolling.
31 December 2030
Quick facts
| Lead sponsor | Ruijin Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 5 September 2025 |
| Primary completion | 31 December 2030 |
| Estimated completion | 31 December 2030 |
| Sites | 1 location across China |
Drugs / interventions tested
- PD-1 inhibitor based immunotherapy — full drug profile →
Conditions studied
- Rectal Cancer — all drugs for Rectal Cancer →
- Rectal Adenocarcinoma — all drugs for Rectal Adenocarcinoma →
- Rectal Cancer, Radiotherapy — all drugs for Rectal Cancer, Radiotherapy →
- Rectal Cancer Patients — all drugs for Rectal Cancer Patients →
Sponsor
Ruijin Hospital
Who can join
Adults 18 to 75, any sex, with Rectal Cancer or Rectal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07198165
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Rectal Cancer
Currently open trials in the same condition.
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
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- NCT07501845 — Registry Maastro Applicator · recruiting
- NCT07369531 — The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-pres · NA · recruiting
- NCT07505472 — Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Wit · Phase 2, PHASE3 · recruiting
Other Ruijin Hospital trials
Trials by the same sponsor.
- NCT07589361 — Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors · not yet recruiting
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- NCT07496385 — Clinical Study on the Efficacy of Subglottic Suction in Mechanically Ventilated Patients Guided by Bedside Ultrasound · NA · not yet recruiting
- NCT07511114 — A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyp · Phase 3 · not yet recruiting
- NCT07514169 — The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL · Phase 2 · not yet 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 NCT07198165 (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 Ruijin Hospital
- Last refreshed: 30 September 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/NCT07198165.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing