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NCT05218148
SOX Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of HER2-positive Locally Advanced Gastric Adenocarcinoma
Phase 2 trial testing sintilimab in HER2-positive in 44 participants. Status unknown.
1 October 2024
Quick facts
| Lead sponsor | Aiping Zhou |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 1 April 2022 |
| Primary completion | 1 October 2024 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- sintilimab — full drug profile →
- Trastuzumab (trastuzumab) — full drug profile →
- S-1 plus oxaliplatin — full drug profile →
Conditions studied
- HER2-positive — all drugs for HER2-positive →
- Locally Advanced Solid Tumor — all drugs for Locally Advanced Solid Tumor →
- Immunotherapy — all drugs for Immunotherapy →
- Sintilimab — all drugs for Sintilimab →
Sponsor
Aiping Zhou — full company profile →
Who can join
Adults 18 to 75, any sex, with HER2-positive or Locally Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The SOX regimen has became the standard perioperative chemotherapy for locally advanced gastric cancer; The immune checkpoint inhibitors have become a standard treatment for advanced or metastatic gastric cancer；For HER2-positive locally advanced gastric cancer, some phase II studies have shown that chemotherapy combined with trastuzumab can further improve the pathological remission rate;This prospective phase II clinical trial was designed, using SOX combined with sintilimab and trastuzumab to treat HER2 positive locally advanced gastric or gastroesophageal junction adenocarcinoma patients.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current state of the art: immunotherapy in esophageal cancer and gastroesophageal junction cancer.
Li N, Sohal D. · · 2023 · cited 22× · PMID 37995002 · DOI 10.1007/s00262-023-03566-5 -
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 -
Application of immune checkpoint inhibitors for resectable gastric/gastroesophageal cancer.
Lin F, Chen Y, Huang B, Ruan S, et al · · 2024 · cited 4× · PMID 38783944 · DOI 10.3389/fphar.2024.1391562 -
Advancements in targeted therapy for gastric cancer.
Wang Y, Li J, Liu G, Zhang C, et al · · 2026 · PMID 42004816 · DOI 10.1177/17562848261439234 -
Additions of trastuzumab to preoperative chemotherapy or chemoimmunotherapy for patients with potentially resectable stage III to IV<sub>B</sub> HER2-positive gastric cancer.
Zhang X, Tian Y, Wang H, Song S, et al · · 2025 · PMID 40755752 · DOI 10.3389/fimmu.2025.1624943
Verify or expand the search:
- PubMed search for NCT05218148
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of sintilimab
Trials testing the same drug.
- NCT07487662 — TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcin · Phase 2 · not yet recruiting
- NCT07018063 — Neoadjuvant Nab-Paclitaxel Plus Oxaliplatin, S-1, and Sintilimab in Early-Onset Resectable Gastric Cancer · Phase 2 · not yet recruiting
- NCT07007767 — Exploring Sintilimab + Bevacizumab + Decitabine for Advanced pMMR/MSS Colorectal Cancer (After 2+ Prior Therapies） · Phase 2 · not yet recruiting
- NCT05562297 — Neoadjuvant/Adjuvant Sintilimab, Nab-paclitaxel, and Gemcitabine for Resectable/Borderline Resectable Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT06584032 — Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer · Phase 3 · recruiting
Other recruiting trials for HER2-positive
Currently open trials in the same condition.
- NCT07108127 — Efficacy and Safety of Trastuzumab Biosimilars and Pertuzumab Biosimilars Combined With Chemotherapy for Neoadjuvant Tre · Phase 2 · recruiting
- NCT06254807 — CAR-monocytes for the Treatment of HER2 Overexpressing Solid Tumors · Phase 1 · active not recruiting
- NCT05035836 — A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive · Phase 2 · recruiting
- NCT04660929 — CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors · Phase 1 · active not recruiting
Other Aiping Zhou trials
Trials by the same sponsor.
- NCT04695470 — Phase II Trial of Fruquintinib With Sintilimab in Treating Selected Refractory Metastatic Colorectal Cancer Patients · Phase 2 · unknown
- NCT04694404 — Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced Gastric Cancer · Phase 2 · unknown
- NCT03830606 — The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma · Phase 2 · completed
- NCT03443661 — Neoadjuvant Triplet Chemotherapy Regimen in Patients With Locally Advanced Rectal Cancer · Phase 2 · completed
- NCT03415802 — Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer · Phase 2 · completed
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 NCT05218148 (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 Aiping Zhou
- Last refreshed: 6 April 2022
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/NCT05218148.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing