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NCT06108596: PICS
Evaluation of the Efficacy and Safety of Interleucin-2 Combined With PD-1 Monoclonal Antibody and CAPOX in Preoperative Neoadjuvant Therapy for Mid-low Locally Advanced Rectal Cancer - a Single-center, Single-arm, Open-label Clinical Trail
Phase 2 trial testing Sintilimab with Interleukin-2+CAPOX in Locally Advanced Rectal Adenocarcinoma in 33 participants. Completed in 31 December 2024.
31 December 2024
Quick facts
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 21 October 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sintilimab with Interleukin-2+CAPOX — full drug profile →
Conditions studied
- Locally Advanced Rectal Adenocarcinoma — all drugs for Locally Advanced Rectal Adenocarcinoma →
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Who can join
Adults 18 to 75, any sex, with Locally Advanced Rectal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Evaluation of the efficacy and safety of interleucin-2 combined with PD-1 monoclonal antibody and CAPOX in preoperative neoadjuvant therapy for mid-lower locally advanced rectal cancer - a single-center, single-arm, open-label clinical trail.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Total neoadjuvant chemotherapy combined with PD‑1 blockade and IL‑2 in MSS/pMMR locally advanced rectal cancer: short-term results of a prospective, single-arm phase II study.
Tang J, Wang L, Yang S, Peng W, et al · · 2026 · PMID 42071008 · DOI 10.1038/s41392-026-02683-8
Verify or expand the search:
- PubMed search for NCT06108596
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Locally Advanced Rectal Adenocarcinoma
Currently open trials in the same condition.
- NCT06834126 — Papaverine in Combination With Radiation Therapy for the Treatment of Locally Advanced Rectal Cancer, DINOMITE Trial · Phase 1 · recruiting
- NCT06843434 — A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma · Phase 2 · recruiting
- NCT05672524 — A Study of Tucatinib and Trastuzumab in People With Rectal Cancer · Phase 2 · recruiting
- NCT04751370 — Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer · Phase 2 · active not recruiting
- NCT04130854 — INNATE: Immunotherapy During Neoadjuvant Therapy for Rectal Cancer · Phase 2 · active not recruiting
Other The First Affiliated Hospital with Nanjing Medical University trials
Trials by the same sponsor.
- NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
- NCT07523789 — Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC · not yet recruiting
- NCT07464756 — SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer · Phase 2 · not yet recruiting
- NCT07482826 — Full-Endoscopic Decompression vs. Endoscopic Lumbar Fusion for Middle-Aged and Older Adults With Spinal Stenosis · NA · not yet recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · 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 NCT06108596 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital with Nanjing Medical University
- Last refreshed: 21 January 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/NCT06108596.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing