Advanced Gastric Cancer Clinical Trial
Official title:
A Phase III Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Paclitaxel Versus Paclitaxel Alone in Second Line Gastric Cancer
Fruquintinib once daily in 4 weeks treatment cycle (three weeks on and one week off) in combination with Paclitaxel 80mg/㎡（day1, 8, 15 of 4 weeks cycle) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC in ph1b/2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in combination with Paclitaxel in the treatment of patients with aGC who have progressed after first line standard chemotherapy.
This is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial to compare the efficacy and safety of Fruquintinib combined with Paclitaxel versus Paclitaxel alone in patients with advanced gastric cancer who have progressed after first-line standard chemotherapy. After checking eligibility criteria, subjects will be randomized into Fruquintinib combined with Paclitaxel group (treatment group) or placebo combined with Paclitaxel group (control group) in a ratio of 1:1. Primary Efficacy Endpoint: Overall Survival (OS), Progression free survival (PFS) (According to RECIST Version 1.1). Secondary Efficacy Endpoints: Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DOR), EORTC QLQ-C30 (V3) .Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.03. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05028933 -
IMC001 for Clinical Research on Advanced Digestive System Malignancies
|
Phase 1 | |
| Completed |
NCT00821990 -
Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer
|
Phase 3 | |
| Recruiting |
NCT04385641 -
Study on the Safety and Effectiveness of UCB-NK Cell Infusion in the Treatment of Advanced Gastric Cancer and Gastroesophageal Cancer
|
N/A | |
| Completed |
NCT01248403 -
A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy
|
Phase 3 | |
| Not yet recruiting |
NCT01206218 -
Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT01851941 -
A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer
|
Phase 2 | |
| Completed |
NCT00976768 -
Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Failure of Prior Taxane, Fluoropyrimidine, and Cisplatin
|
Phase 2 | |
| Completed |
NCT03609359 -
Lenvatinib and Pembrolizumab Simultaneous Combination Study
|
Phase 2 | |
| Completed |
NCT03350477 -
Bioinformation Therapy for Gastric Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT02935634 -
A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03579784 -
Biomarker-oriented Study of Durvalumab (MEDI4736) in Combination With Olaparib and Paclitaxel in Gastric Cancer
|
Phase 2 | |
| Completed |
NCT02952729 -
Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2
|
Phase 1 | |
| Recruiting |
NCT02072317 -
Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer
|
Phase 2 | |
| Completed |
NCT01472250 -
A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in China
|
N/A | |
| Completed |
NCT01503372 -
FLO +/- Pazopanib as First-line Treatment in Advanced Gastric Cancer
|
Phase 2 | |
| Terminated |
NCT01402401 -
Phase II of AUY922 in Second-line Gastric Cancer in Combination With Trastuzumab in HER2 Positive Patients
|
Phase 2 | |
| Recruiting |
NCT01015339 -
Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
|
Phase 3 | |
| Completed |
NCT00842491 -
Study of Endostar With Cisplatin and Capecitabine as 1st Line Treatment in the Advanced Gastric Cancer
|
Phase 2 | |
| Completed |
NCT01441336 -
Laparoscopic Gastrectomy for Advanced Gastric Cancer
|
Phase 2 | |
| Completed |
NCT02071043 -
Trial of Xeloda and Oxaliplatin (XELOX) as Neo-adjuvant Chemotherapy Followed by Surgery in Advanced Gastric Cancer Patients With Para-aortic Lymph Node Metastasis
|
Phase 2 |