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

NCT03223376 | Completed Phase 3 DMC

• 1 other identifier: 2017-013-00CH1
• Study Type: interventional
• Target: 703
• Locations: 1 country
• Sites: 7

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.

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  every two months follow up after EOT observation period at 30 days after the last medication

  from randomization until death due to any cause, assessed up to 3 year

• Progression free survival (PFS)

  PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.

  from the date of randomization to the date of the first documented progressive disease or date of death due to any cause, assessed up to 1 year]

Secondary Outcomes (5)

• Objective response rate (ORR)

  from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year

• Disease control rate (DCR)

  from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year

• Safety and tolerance evaluated by incidence, severity and outcomes of AEs

  from first dose to 30 days post the last dose

• Duration of response, DOR

  : From the first documented PR or CR until the first documented PD or death，assessed up to 2 years

• The European Organization for Reasearch and Treatment of Cancer（EORTC ） Quality of Life Questionnaire-Core 30 V3.0 (QLQ-C30 v3.0)

  Evaluation before the beginning of each treatment cycle, at the end of treatment, and at the 30 days post the last dose，up to 2 years

Study Arms (2)

fruquintinib+paclitaxel

ACTIVE COMPARATOR

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

Combination Product: fruquintinib +paclitaxel

placebo+paclitaxel

PLACEBO COMPARATOR

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

Combination Product: fruquintinib placebo + paclitaxel

Interventions

fruquintinib +paclitaxel 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.

Also known as: HMPL-013+paclitaxel

fruquintinib+paclitaxel

fruquintinib placebo + paclitaxel 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.

Also known as: HMPL-013 placebo+paclitaxel

placebo+paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead
• Sun Yat-sen University: collaborator

Study Sites (7)

Hutchison Medi Pharma Invesigational sites

Hefei, Anhui, 230000, China

Location

Hutchison Medi Pharma Investigational Site

Guangzhou, Guangdong, 510030, China

Location

Hutchison Medi Pharma Investigational site

Harbin, Heilongjiang, 150081, China

Location

Huchison Medi Pharma Investigational site

Nanjing, Jiangsu, 210000, China

Location

Hutchison Medi Pharma Investigational sites

Hangzhou, Zhejiang, 310000, China

Location

Hutchison Medi Pharma Investigational sites

Beijing, 100142, China

Location

Hutchison Medi Pharma Investigational site

Shanghai, 200125, China

Location

Related Publications (1)

• 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.

  PMID: 38824242 DERIVED

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ruihua Xu, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: October 18, 2017
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CN (7)