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NCT06329973
Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer
Phase 1, PHASE2 trial testing Fruquintinib in combination with Sintilimab and CAPEOX in Metastatic Gastroesophageal Junction Adenocarcinoma in 70 participants. Currently enrolling.
28 June 2026
Quick facts
| Lead sponsor | Henan Cancer Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 28 February 2024 |
| Primary completion | 28 June 2026 |
| Estimated completion | 28 June 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Fruquintinib in combination with Sintilimab and CAPEOX — full drug profile →
Conditions studied
- Metastatic Gastroesophageal Junction Adenocarcinoma — all drugs for Metastatic Gastroesophageal Junction Adenocarcinoma →
Sponsor
Henan Cancer Hospital
Who can join
Adults 18 to 75, any sex, with Metastatic Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Single-arm, open-label, multicentre phase 1b/2 study to evaluate the safety and efficacy of fruquintinib combined with sintilimab and CAPEOX as a first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma (FUNCTION study): a study protocol.
Chen B, Zhao J, Lv H, Xu W, et al · · 2025 · cited 1× · PMID 41005780 · DOI 10.1136/bmjopen-2025-100241
Verify or expand the search:
- PubMed search for NCT06329973
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Henan Cancer Hospital 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 NCT06329973 (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 Henan Cancer Hospital
- Last refreshed: 17 July 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/NCT06329973.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing