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NCT03985891: JSFOL
The Efficacy of JS001 Combined With Chemotherapy in Patients With Locally Advanced Colon Cancer
Phase 1, PHASE2 trial testing Anti-PD-1 Monoclonal Antibody JS001 in Colonic Neoplasms in 40 participants. Currently enrolling.
1 June 2025
Quick facts
| Lead sponsor | Xiangya Hospital of Central South University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 16 December 2020 |
| Primary completion | 1 June 2025 |
| Estimated completion | 1 June 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Anti-PD-1 Monoclonal Antibody JS001 — full drug profile →
- Chemotherapy (chemotherapy) — full drug profile →
Conditions studied
- Colonic Neoplasms — all drugs for Colonic Neoplasms →
- Chemotherapy Effect — all drugs for Chemotherapy Effect →
Sponsor
Xiangya Hospital of Central South University
Who can join
Adults 18 to 70, any sex, with Colonic Neoplasms or Chemotherapy Effect. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Colon cancer is one of the most lethal malignancies, and colorectal cancer ranks the fifth leading cause of tumor-related mortality in China. FOLFOX is the recommended adjuvant/ neoadjuvant treatment for advanced colon cancer. JS001, as the first Chinese produced anti-PD-1 monoclonal antibody, has been approved by CFDA. This study aims to assess the safety and efficacy of JS001 in combination with FOLFOX as adjuvant/neoadjuvant treatment for patients with locally advanced colon cancer.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neoadjuvant Immunotherapy for MSI-H/dMMR Locally Advanced Colorectal Cancer: New Strategies and Unveiled Opportunities.
Zhang X, Wu T, Cai X, Dong J, et al · · 2022 · cited 99× · PMID 35371084 · DOI 10.3389/fimmu.2022.795972 -
Neoadjuvant immunotherapy for colorectal cancer: Right regimens, right patients, right directions?
Zhu J, Lian J, Xu B, Pang X, et al · · 2023 · cited 38× · PMID 36949951 · DOI 10.3389/fimmu.2023.1120684 -
Neoadjuvant Chemotherapy for Colon Cancer
Roth MT, Eng C. · · 2020 · cited 18× · PMID 32825640 · DOI 10.3390/cancers12092368 -
Immunotherapy during the Immediate Perioperative Period: A Promising Approach against Metastatic Disease.
Sandbank E, Eckerling A, Margalit A, Sorski L, et al · · 2023 · cited 10× · PMID 37623021 · DOI 10.3390/curroncol30080540 -
Preoperative Strategies for Locally Advanced Colon Cancer.
Nair KG, Kamath SD, Chowattukunnel N, Krishnamurthi SS. · · 2024 · cited 5× · PMID 38349502 · DOI 10.1007/s11864-024-01184-6 -
Neoadjuvant mFOLFOX6 plus camrelizumab and apatinib in colon cancer and biomarker research via spatiotemporal-omics profiling.
Tong Z, Gao L, Wang D, Zhao P, et al · · 2026 · PMID 41922688 · DOI 10.1038/s41698-026-01387-0
Verify or expand the search:
- PubMed search for NCT03985891
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Xiangya Hospital of Central South 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 NCT03985891 (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 Xiangya Hospital of Central South University
- Last refreshed: 17 December 2020
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/NCT03985891.
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