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Advanced Gastric CancerPhase 3FRUTIGANCT03223376

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

A Phase 3 study testing fruquintinib +paclitaxel in people with Advanced Gastric Cancer, run by Hutchison Medipharma Limited at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Gastric Cancer
What is being tested?
fruquintinib +paclitaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
703 participants
Where
7 sitesChina
Study dates
18 Oct 2017to 9 Sep 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Hutchison Medi Pharma Investigational sites

    Beijing, 100142

  • Hutchison Medi Pharma Investigational Site

    Guangzhou, Guangdong, 510030

  • Hutchison Medi Pharma Investigational sites

    Hangzhou, Zhejiang, 310000

  • Hutchison Medi Pharma Investigational site

    Harbin, Heilongjiang, 150081

  • Hutchison Medi Pharma Invesigational sites

    Hefei, Anhui, 230000

  • Huchison Medi Pharma Investigational site

    Nanjing, Jiangsu, 210000

  • Hutchison Medi Pharma Investigational site

    Shanghai, 200125

Other trials in China

About this study

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.

Read the 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.

Being tested
fruquintinib +paclitaxel, fruquintinib placebo + paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fruquintinib +paclitaxelCombination product

    Also called HMPL-013+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.

  • fruquintinib placebo + paclitaxelCombination product

    Also called HMPL-013 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.

Study groups in NCT03223376
Study groupRoleWhat they receive
fruquintinib+paclitaxelActive comparatortreatment arm (fruquintinib+paclitaxel) : Fruquintinib once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.
Receives: Combination Product: fruquintinib +paclitaxel
placebo+paclitaxelPlacebo comparatorcontrol arm (placebo+paclitaxel): Fruquintinib placebo once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.
Receives: Combination Product: fruquintinib placebo + paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

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

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

  2. 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.

    Measured: 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)

  1. Objective response rate (ORR)

    Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

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

  2. Disease control rate (DCR)

    Tumor assessment will be performed using radiography method every 8 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1

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

  3. Safety and tolerance evaluated by incidence, severity and outcomes of AEs

    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

    Measured: from first dose to 30 days post the last dose

  4. Duration of response, DOR

    DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1.

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

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

    EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status. There are 30 items in total, which can be divided into 15 fields. Five functional scales: physical function, role function, cognitive function, emotional function, social function; Three symptom scales: fatigue, pain, nausea and vomiting; Six individual measures: dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties, and a global quality of life scale. The five functional scales and the global quality of life scale were scored independently. After linear transformation, the scores of all items ranged from 1 to 100, and the higher score, the higher functional level. The symptom scale was also scored independently and linearly transformed into a score from 1 to 100, with higher scores indicating more serious problems or symptoms.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2017
  2. Study start18 Oct 2017
  3. Primary completion9 Sep 2022
  4. Study completion9 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
703 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03223376
Sponsor's protocol ID
2017-013-00CH1
Acronym
FRUTIGA
Status last verified
Nov 2025
First submitted
18 Jul 2017
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38824242

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fruquintinib +paclitaxel in people with Advanced Gastric Cancer, run by Hutchison Medipharma Limited at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: from randomization until death due to any cause, assessed up to 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223376, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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