Gastric Adenocarcinoma Clinical Trial
Official title:
Phase Ib/IIa, Two-stage Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients
Gastric cancer have poor prognosis and majority of patients resistant to 5-FU/DDP based first-line chemotherapy in China. There was no recommended second-line chemotherapy for advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound Paclitaxel (Abraxane，ABI-007) has good convenience to use and been approved in breast cancer in many countries. The investigator then initiated a prospective phase Ib/IIa clinical trial with nab-paclitaxel plus TS-1 as the second-line treatment in advanced gastric cancer to observe the safety and efficacy.
This study is a two-stage design. Stage 1
The investigator should evaluate two recommend dose and tolerability of nab-paclitaxel plus
S-1 after one course of treatment as 3+1 design:
nab-paclitaxel should be given intravenously on days 1 and 8 at a dose as follows, Treatment
should be repeated every 3 weeks: Treatment arm A：125 mg /m2; Treatment arm B：100 mg /m2;
Treatment arm C: 80 mg /m2; S-1 should be given orally twice a day as follows for 14
consecutive days, followed by a 1-week rest. Treatment should be repeated every 3 weeks. BSA
＜ 1.5 m2，40mg，bid;BSA ≥ 1.5 m2，50mg，bid.
The investigator should determine whether to continue the original regimen; compare the
safety and pharmacokinetic results with original profile of combination therapy to select
the best therapy programs (RD, recommended dose).
Stage 2 According to two-stage design (Simon,1989), re-entry subjects to the recommended
dose group to a total of 25 valid cases. If 11 patients achieve response, then enter the
second phase of total 66 patients.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05977998 -
A Phase II Study of Perioperative Paclitaxel in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
|
Phase 2 | |
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
| Recruiting |
NCT03257163 -
Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer
|
Phase 2 | |
| Completed |
NCT02128243 -
Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
|
Phase 2 | |
| Completed |
NCT01178944 -
Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
|
Phase 2 | |
| Terminated |
NCT00209079 -
Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma
|
Phase 2 | |
| Terminated |
NCT02862535 -
Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma
|
Phase 1 | |
| Active, not recruiting |
NCT05008783 -
A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ Adenocarcinoma
|
Phase 3 | |
| Recruiting |
NCT04430738 -
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04114136 -
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
|
Phase 2 | |
| Completed |
NCT03196232 -
Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer
|
Phase 2 | |
| Recruiting |
NCT04047953 -
Paclitaxel (Albumin-bound) Combined With Oxaliplatin and S-1 Conversion Therapy for Gastric Adenocarcinoma
|
N/A | |
| Completed |
NCT02891447 -
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer
|
Phase 2 | |
| Completed |
NCT02864381 -
Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
|
Phase 2 | |
| Terminated |
NCT04032704 -
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors
|
Phase 2 | |
| Terminated |
NCT04604132 -
Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02830594 -
Pembrolizumab and Palliative Radiation Therapy in Treating Patients With Metastatic Esophagus, Stomach, or Gastroesophageal Junction Cancer
|
Phase 2 | |
| Recruiting |
NCT06038578 -
A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
|
Phase 2 | |
| Terminated |
NCT04099277 -
A Study of LY3435151 in Participants With Solid Tumors
|
Phase 1 |