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NCT06923345
Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIFI-RC-I)
Phase 2 trial testing Reduced CTV in Rectal Cancer in 80 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 31 March 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Reduced CTV
- Conventional CTV
Conditions studied
- Rectal Cancer — all drugs for Rectal Cancer →
- Neoadjuvant Therapies — all drugs for Neoadjuvant Therapies →
- Immune Checkpoint Therapy — all drugs for Immune Checkpoint Therapy →
- Radiotherapy — all drugs for Radiotherapy →
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Who can join
Adults 18 to 75, any sex, with Rectal Cancer or Neoadjuvant Therapies. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to evaluate whether a total neoadjuvant therapy (TNT) regimen combining long-course chemoradiotherapy, sequential chemotherapy, and PD-1 inhibitor can improve response rates, enhance tolerability, and improve prognosis in patients with locally advanced, microsatellite-stable (MSS) rectal cancer. The main questions it aims to answer are: Does this TNT approach improve complete response (CR) rates? How does selective reduction of clinical target volume (CTV) to S2/S3 level compare with conventional CTV irradiation in terms of efficacy and safety? Researchers will compare a selective CTV reduction group and a conventional CTV irradiation group to assess differences in treatment outcomes, including complete response, tumor regression grading (TRG), organ preservation, R0 resection rates, and long-term survival. Participants will: Receive long-course chemoradiotherapy with either conventional or reduced CTV irradiation. Undergo sequential chemotherapy. Receive PD-1 inhibitor treatment. Be monitored for safety, tumor regression, and long-term survival outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06923345
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Sixth Affiliated Hospital, Sun Yat-sen 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 NCT06923345 (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 Sixth Affiliated Hospital, Sun Yat-sen University
- Last refreshed: 18 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/NCT06923345.
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