A Phase III Study of Fruquintinib in Combination With Paclitaxel in Second Line Gastric Cancer(FRUTIGA)

NCT ID: NCT03223376

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 703 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-18
• Study Completion Date: 2022-09-09

Brief Summary

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.

Detailed Description

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.

Conditions

Advanced Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

fruquintinib+paclitaxel

treatment arm (fruquintinib+paclitaxel) : Fruquintinib once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.

Group Type: ACTIVE_COMPARATOR

fruquintinib +paclitaxel

Intervention Type: COMBINATION_PRODUCT

treatment arm(fruquintinib +paclitaxel)- subjects will receive Fruquintinib orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

placebo+paclitaxel

control arm (placebo+paclitaxel): Fruquintinib placebo once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.

Group Type: PLACEBO_COMPARATOR

fruquintinib placebo + paclitaxel

Intervention Type: COMBINATION_PRODUCT

control arm(fruquintinib placebo + paclitaxel)- subjects will receive Fruquintinib placebo orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

Interventions

fruquintinib placebo + paclitaxel

control arm(fruquintinib placebo + paclitaxel)- subjects will receive Fruquintinib placebo orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

Intervention Type: COMBINATION_PRODUCT

fruquintinib +paclitaxel

treatment arm(fruquintinib +paclitaxel)- subjects will receive Fruquintinib orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

HMPL-013+paclitaxel; HMPL-013 placebo+paclitaxel

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma
• Metastatic disease or locally advanced, unresectable disease
• Disease progression during or within 4 months after the last dose of the first-line therapy (with platinum/fluoropyrimidine )
• Adequate hepatic, renal, heart, and hematologic functions
• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
• Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1

Exclusion Criteria

• Pregnant or lactating women
• Any factors that influence the usage of oral administration
• Evidence of CNS metastasis
• Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
• Abuse of alcohol or drugs
• Less than 4 weeks from the last clinical trial
• Previous treatment with VEGFR inhibition
• Disability of serious uncontrolled intercurrence infection
• Proteinuria ≥ 2+ (1.0g/24hr)
• Have evidence or a history of bleeding tendency within two months of the enrollment randomization, regardless of seriousness
• Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
• Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG
• Bone fracture or wounds that was not cured for a long time
• Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant Therapy
• The tumor invades a large vessel structure, such as the pulmonary artery, superior vena cava, or inferior vena cava

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Hutchison Medipharma Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruihua Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Hutchison Medi Pharma Invesigational sites

Hefei, Anhui, China

Hutchison Medi Pharma Investigational Site

Guangzhou, Guangdong, China

Hutchison Medi Pharma Investigational site

Harbin, Heilongjiang, China

Huchison Medi Pharma Investigational site

Nanjing, Jiangsu, China

Hutchison Medi Pharma Investigational sites

Hangzhou, Zhejiang, China

Hutchison Medi Pharma Investigational sites

Beijing, , China

Hutchison Medi Pharma Investigational site

Shanghai, , China

Countries

China

References

Wang F, Shen L, Guo W, Liu T, Li J, Qin S, Bai Y, Chen Z, Wang J, Pan Y, Shu Y, Zhao F, Cheng Y, Ye F, Gu K, Zhang T, Pan H, Zhong H, Zhou F, Qin Y, Yang L, Mao W, Li Q, Dai W, Li W, Wang S, Tang Y, Ma D, Yin X, Deng Y, Yuan Y, Li M, Hu W, Chen D, Li G, Liu Q, Tan P, Fan S, Shi M, Su W, Xu RH. Fruquintinib plus paclitaxel versus placebo plus paclitaxel for gastric or gastroesophageal junction adenocarcinoma: the randomized phase 3 FRUTIGA trial. Nat Med. 2024 Aug;30(8):2189-2198. doi: 10.1038/s41591-024-02989-6. Epub 2024 Jun 1.

Reference Type: DERIVED

PMID: 38824242 (View on PubMed)

Other Identifiers

2017-013-00CH1

Identifier Type: -

Identifier Source: org_study_id