Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TOTMS1311 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In China, S-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. The new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. This study is aimed to evaluate the feasibility of the SOL regimen on efficacy and tolerability on Chinese patients with advanced gastric cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOL, single arm | Experimental | S-1 combined with leucovorin and oxaliplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1, leucovorin, oxaliplatin | Drug | S-1 (20mg), capsule, 40-60mg, bid, p.o., day1-14; Leucovorin (15 mg), tablet, 30mg,Bid, p.o., day1-14; Oxaliplatin (50 mg), injection 85mg/m2, day1. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Evaluate the objective response rate followed by RECIST 1.1. | 6-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, The number of Participants with adverse events will be recorded at each treatment visit. | 1 year |
| Overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 2 upper limit of normal range (ULN);
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Zhang, MD, Ph.D | Contact | +86-0431-85872596 | JPCH2013@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin Provincial Tumor Hospital | Recruiting | Changchun | Jilin | China |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D036881 | Long-Term Synaptic Depression |
| D005575 | Formyltetrahydrofolates |
| ID | Term |
|---|---|
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3 year |
| Progress free survival | Tumor assessment will be performed every 3 cycles (9 weeks) from the start of treatment until progression or as for the metastatic site developed during the study (including clinical suspicion). In order to confirm objective tumor response, additional confirmatory scan should be obtained at least 4 weeks following the first radiological evidence of tumor response. | up to 9 weeks |
| Disease control rate | To Assess disease control rate (DCR) as defined CR + PR + SD assessed by RECIST criteria | up to 9 weeks |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |