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NCT06928584
Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer
Phase 2 trial testing Conventional Radiotherapy in Locally Recurrent Rectal Cancer in 221 participants. Currently enrolling.
10 March 2030
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 221 |
| Start date | 10 March 2025 |
| Primary completion | 10 March 2030 |
| Estimated completion | 10 March 2030 |
| Sites | 1 location across China |
Drugs / interventions tested
- Conventional Radiotherapy
- Capecitabine (capecitabine) — full drug profile →
- 5-fluorouracil
- folinic acid — full drug profile →
- Oxaliplatin (Oxaliplatin) — full drug profile →
- Irinotecan
- Cetuximab (cetuximab) — full drug profile →
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
- Hypofractionated radiotherapy
- PD-1 antibody
Conditions studied
- Locally Recurrent Rectal Cancer — all drugs for Locally Recurrent Rectal Cancer →
Sponsor
Fudan University
Who can join
Adults 18 to 75, any sex, with Locally Recurrent Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
TORCH-R2 is a prospective, multicenter, randomized, phase II clinical trial. Patients aged 18 years or older with pelvic recurrence rectal cancer without synchronous distant metastases or recent chemo- and/or radiotherapy treatment, Eastern Cooperative Oncology Group performance status of 0-1will be enrolled . Patients will be randomized to receive either hypofractionated radiotherapy (25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation), 18 weeks sintilimab and investigator's choice of first-line chemotherapy +/- target therapy (experimental arm), or conventional radiotherapy (50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation) and chemotherapy +/- target therapy (control arm). Patiens will be restaged and followed by multidisciplinary team (MDT) for decision: radical surgery, sustained systerm+/- local treatment of non resection. The primary endpoint was progression-free survival. Secondary endpoints were objective response rate (ORR), complete response rate, R0 resection rate, duration of response (DOR), overall survival (OS), and safety and tolerability of the treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06928584
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Locally Recurrent Rectal Cancer
Currently open trials in the same condition.
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- NCT05877352 — Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial · NA · active not recruiting
Other Fudan University trials
Trials by the same sponsor.
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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 NCT06928584 (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 Fudan University
- Last refreshed: 15 April 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/NCT06928584.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing