Clinical trial · Interventional
Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers
An Phase I Dose-Escalation Study of Biweekly Abraxane in Combination With Oxaliplatin and Oral S-1/LV (SOLAR Regimen) as First-line Chemotherapy in Patients With Advanced Gastric, Pancreatic and Biliary Cancers
- 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)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Cancers | — | UNRESOLVED | — |
| Gastric Cancer in Situ | — | UNRESOLVED | — |
| Pancreatic Cancers | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-Bound Paclitaxel /nab-Paclitaxel | Drug | — | UNRESOLVED |
| LV | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SOLAR
- description
- Albumin-Bound Paclitaxel /nab-Paclitaxel (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60\~ 85 mg/m2 IVD 2hr at D1, plus Tegafur,oral S-1 35mg/m2 and Folinic acid/LV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression
- interventionNames
- Drug: Oxaliplatin
- Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel
- Drug: S-1
- Drug: LV
Primary outcomes (1)
- measure
- MTD of Oxaliplatin
- timeFrame
- From date of registration until the date of definition of MTD or first documented progression or date of death from any cause, whichever came first, assessed up to 28weeks.
- description
- Dose-limiting toxicity (DLT),patients will be enrolled in cohort of 3 to receive escalating dose of Oxaliplatin at three dose levels (level I, 60 mg/m2, level II, 75 mg/m2 and level III, 85 mg/m2)or more of defined events.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed adenocarcinoma or carcinoma of the stomach, pancreas and biliary tract with unresectable, recurrence or metastatic disease. * No prior systemic chemotherapy except adjuvant chemotherapy that has completed 6 months prior enrollment. * Palliative RT to bone but not the primary, main tumor site is permitted. * At least one measurable lesion over non-radiated site. * Aged between 20 to 70 years old. * ECOG Performance Status \<= 1. * Life expectancy greater than 12 weeks. * Adequate bone marrow function : absolutely neutrophil count \>= 1.5 x 109/L or WBC \>= 4 x 109/L, hemoglobin \>= 9 g/dl, platelet count 100 x 109/L * Adequate liver function : ALT \<= 2.5 x ULN and Bilirubin \< 1.5 x ULN * Adequate renal function: creatinine \< 1.5 x ULN and calculated eGFR\> 50 mL/min. Exclusion Criteria: * Major surgery within four weeks prior to study enrolment. * Patient with Ampulla vater cancer is excluded. * Patients with suspicious or history of CNS metastasis. * Patients who with active or uncontrolled infections. * Patients who have history of myocardial infarction or unstable angina within 6 months before entry. * Patients with concomitant illness that might be aggravated by chemotherapy. * Patients who are pregnant or with breast feeding. * Other concomitant or previously malignancy within 3 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin, stage 0-I colon or breast treated by surgery only and without evidence of relapsed tumor. * Mental status is not fit for clinical trial * Fertile men and women unless using a reliable and appropriate contraceptive method.
References
Publications (1)
- DERIVEDTsai HJ, Yang SH, Hsiao CF, Kao HF, Su YY, Shan YS, Yen CJ, Du JS, Hsu C, Wu IC, Chen LT. A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study. Oncologist. 2024 Oct 3;29(10):e1396-e1405. doi: 10.1093/oncolo/oyae109. PMID 38902994