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NCT03162510: SOLAR
Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers
Phase 1 trial testing Oxaliplatin in Gastric Cancer in Situ in 18 participants. Completed in 31 January 2022.
7 June 2021
Quick facts
| Lead sponsor | National Health Research Institutes, Taiwan |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 26 June 2018 |
| Primary completion | 7 June 2021 |
| Estimated completion | 31 January 2022 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Oxaliplatin (Oxaliplatin) — full drug profile →
- Albumin-Bound Paclitaxel /nab-Paclitaxel — full drug profile →
- S-1 — full drug profile →
- LV — full drug profile →
Conditions studied
- Gastric Cancer in Situ — all drugs for Gastric Cancer in Situ →
- Pancreatic Cancers — all drugs for Pancreatic Cancers →
- Biliary Cancers — all drugs for Biliary Cancers →
Sponsor
National Health Research Institutes, Taiwan
Who can join
Adults 20 to 70, any sex, with Gastric Cancer in Situ or Pancreatic Cancers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary purpose of the study is to determine the maximal tolerated dose (MTD) of Oxaliplatin in this phase I study. The secondary objectives are to determine the response rate, progression free survival, overall survival, and safety profiles. Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Case Report: Maintenance Nivolumab in Complete Responder After Multimodality Therapy in Metastatic Pancreatic Adenocarcinoma.
Yang SH, Lee JC, Chen BB, Kuo SH, et al · · 2022 · cited 1× · PMID 35572526 · DOI 10.3389/fimmu.2022.870406 -
A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study.
Tsai HJ, Yang SH, Hsiao CF, Kao HF, et al · · 2024 · PMID 38902994 · DOI 10.1093/oncolo/oyae109
Verify or expand the search:
- PubMed search for NCT03162510
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National Health Research Institutes, Taiwan 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 NCT03162510 (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 National Health Research Institutes, Taiwan
- Last refreshed: 7 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/NCT03162510.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing