Clinical trial · Interventional
Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Gastric/Gastroesophageal Junction Adenocarcinoma
Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma: the Phase 2 Solids-01 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
For locally advanced gastric and gastroesophageal junction adenocarcinoma (cT3-4bNanyM0), perioperative PD-1 antibody combined with chemotherapy can downstage tumor stage, increase the R0 resection rate, and may improve the long-term survival. Combination of perioperative surufatinib, sintilimab and chemotherapy for locally advanced gastric and gastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. Surufatinib, as the oral drug in this study is a small molecule kinase inhibitor that mainly acts on vascular growth factor receptor (VEGFR1, 2,3), fibroblast growth factor receptor 1(FGFR1) and colony stimulating factor 1 receptor (CSF1R). It is a proprietary product developed by Hutchison Whampoa Pharmaceutical (Shanghai, China) Co., LTD. Surufatinib has been approved for neuroendocrine tumor. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative surufatinib in combination with sintilimab and chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastro Esophageal Junction Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| S1 | Drug | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
| Surufatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surufatinib，sintilimab and SOX chemotherapy
- description
- Surufatinib: 250mg qd，d1-21, q3w; Surufatinib: 200mg, ivdrip, d1, q3w; SOX: Oxaliplatin+S-1 S-1:40\~60mg Bid, d1\~14, q3w; Oxaliplatin: 130mg/m2, ivdrip,d1, q3w; Neoadjuvant therapy for 2-4 cycles, adjuvant therapy for 3-5 cycles. After 6 cycles of SOX chemotherapy, Surufatinib + Surufatinib was taken orally until one year.
- interventionNames
- Drug: Surufatinib
- Drug: Sintilimab
- Drug: Oxaliplatin
- Drug: S1
Primary outcomes (1)
- measure
- Pathological complete response（pCR）rate
- timeFrame
- From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks
Secondary outcomes (3)
- measure
- R0 resection rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * signed informed consent * patients age 18-75 years; * Histologically CT/MRI confirmed cT3-4bNanyM0 gastric or GEJ adenocarcinoma; * ECOG 0-1, no surgery contraindications; * Expected survival ≥3 months; Exclusion Criteria: * signs of distant metastases * Prior chemotherapy, radiotherapy, surgery for gastric cancer; * Significant cardiovascular disease * major surgical procedure within 4 weeks prior to initiation of study treatment * current treatment with anti-viral therapy or HBV * pregnancy or breastfeeding * history of malignancy within 5 years prior to screening * Present or history of any autoimmune disease or immune deficiency; * Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent; * There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors. * Poorly controlled hypertension or diabetes;
References
Publications (0)
Data not yet available