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NCT06383559
Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients
Phase 2 trial testing Lenvatinib and Sintilimab in Gastric Cancer in 39 participants. Currently enrolling.
1 July 2026
Quick facts
| Lead sponsor | Tianjin Medical University Cancer Institute and Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 39 |
| Start date | 1 December 2023 |
| Primary completion | 1 July 2026 |
| Estimated completion | 1 September 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Lenvatinib and Sintilimab — full drug profile →
Conditions studied
- Gastric Cancer — all drugs for Gastric Cancer →
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Who can join
18 and older, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with Sintilimab (\>=60kg, 200 mg; \<60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Combination of cadonilimab (PD-1/CTLA-4 bispecific antibody) and apatinib as salvage therapy achieves partial response in MSI-H advanced gastric cancer: a case report.
Zhao J, Li X, Sun X, Xiao R, et al · · 2025 · cited 4× · PMID 40040691 · DOI 10.3389/fimmu.2025.1533700 -
Molecular pathogenesis and novel therapeutic avenues in alpha-fetoprotein-producing gastric cancer.
Liu G, Zhang J, Ji F, Li Z. · · 2026 · PMID 42088224 · DOI 10.3389/fonc.2026.1814851 -
Clinical advances and challenges of anti-angiogenic targeted therapy in gastric cancer.
Wu Z, Ni J, Xu Q. · · 2025 · PMID 41211418 · DOI 10.3389/fonc.2025.1654300
Verify or expand the search:
- PubMed search for NCT06383559
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Tianjin Medical University Cancer Institute and Hospital trials
Trials by the same sponsor.
- NCT07493993 — Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoa · Phase 2 · not yet recruiting
- NCT07515469 — A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD · Phase 2 · not yet recruiting
- NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
- NCT07510594 — A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC · Phase 2 · not yet recruiting
- NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · 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 NCT06383559 (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 Tianjin Medical University Cancer Institute and Hospital
- Last refreshed: 25 April 2024
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/NCT06383559.
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