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NCT07230639: MODIFI-CC
Node-Sparing Hypofractionated Radiotherapy Plus Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advanced Colon Cancer: A Prospective, Randomized, Phase II Trial
Phase 2 trial testing Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitor in Neoadjuvant Therapies in 52 participants. Currently enrolling.
29 August 2030
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 | 52 |
| Start date | 30 August 2025 |
| Primary completion | 29 August 2030 |
| Estimated completion | 31 December 2031 |
| Sites | 1 location across China |
Drugs / interventions tested
- Node-Sparing Radiotherapy(25Gy/5F) plus Chemotherapy and PD-1 inhibitor
- Node-Sparing Radiotherapy(24Gy/4F) plus Chemotherapy and PD-1 inhibitor
Conditions studied
- 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 Neoadjuvant Therapies or Immune Checkpoint Therapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Most colorectal cancers are microsatellite stable (MSS) or mismatch repair-proficient (pMMR) subtypes, which show limited efficacy to PD-1 inhibitors. Radiotherapy can enhance the release of tumor-associated antigens, thereby improving the responsiveness of pMMR/MSS colorectal cancers to PD-1 blockade. Tumor-draining lymph nodes (TDLNs) are critical sites where PD-1 inhibitors exert their antitumor effects; however, previous studies have reported that direct radiation-induced damage and fibrosis may impair lymphatic drainage and antitumor immunity. Early reports have demonstrated a remarkable pathological complete response (pCR) rate of 77.8% with lymph node-sparing short-course radiotherapy (25 Gy in 5 fractions) in locally advanced rectal cancer. In metastatic colorectal cancer, single-fraction high-dose irradiation (6-8 Gy) has been shown to induce robust abscopal effects. Based on these findings, our study aims to evaluate whether lymph node-sparing hypofractionated radiotherapy (25 Gy/5F or 24 Gy/4F) followed sequentially by chemotherapy and PD-1 blockade can increase the pCR rate, improve tolerability, and ultimately enhance outcomes in patients with pMMR/MSS high-risk locally advanced colon cancer.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07230639
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Neoadjuvant Therapies
Currently open trials in the same condition.
- NCT07279077 — Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advance · Phase 2 · recruiting
- NCT06958432 — Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MO · Phase 2, PHASE3 · recruiting
- NCT06923345 — Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIF · Phase 2 · recruiting
- NCT06826079 — Safety and Efficacy Study of Sorbitol With Neoadjuvant Chemotherapy Combined With Tirellizumab (PD-1 Inhibitor) in Patie · Phase 2, PHASE3 · recruiting
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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 NCT07230639 (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: 26 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/NCT07230639.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing