Gastric (Stomach) CancerPhase 1/2NCT06871527
Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer
A Phase 1/2 study testing fruquintinib + tislelizumab + FOLFOX in people with Gastric (Stomach) Cancer and Gastric Adenocarcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric (Stomach) Cancer, Gastric Adenocarcinoma, Fruquintinib
- What is being tested?
- fruquintinib + tislelizumab + FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- 18-75 years old (including 18 and 75 years old);
- Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
- Pathologically determined gastric or gastroesophageal junction adenocarcinoma;
- Advanced patients with radiographic confirmation of inoperable complete resection;
- No previous anti-tumor treatment for metastatic diseases;
- At least one measurable lesion according to RECIST version 1.1;
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- Ability to take medications orally;
- No active bleeding;
- Adequate organ functions:
- Absolute neutrophil count ≥2×109/L; Platelet ≥100×109/L; Hemoglobin ≥90g/L; WBC≥4×109/L Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN ； Serum creatinine (Cr) ≤1.5XULN；
- Have fully understood the study and voluntarily signed the informed consent;
Who cannot join
- Patients who had received any drug in the study protocol in the last year;
- Deficient mismatch repair (dMMR) or MSI-H detected by genetic test;
- HER2 positive（HER-2 3+, or HER-2 2+ and FISH+）;
- Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
- Patients with acute coronary syndromes (including myocardial infarction and unstable angina) received coronary angioplasty or stenting within 6 months before enrollment;
- Patients with massive pleural or peritoneal effusion requiring drainage;
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- Patients with severe ECG abnormalities or heart diseases (such as cardiac insufficiency, myocardial infarction, angina pectoris) that affect clinical treatment;
- Severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
- Mental disorders or central nervous system diseases or brain metastases affecting clinical treatment;
- Patients with autoimmune diseases;
- Patients with grade 3 or higher bleeding within 4 weeks;
- Patients with a history of allergy to any drug, similar drug or vehicle in this study;
- Had a major surgical procedure (thoracotomy, or laparotomy , etc.) within 4 weeks prior to the first dose of study therapy;
- Patients with nonhealed wounds, ulcers, or fractures;
- Patients who required systemic corticosteroids (excluding temporary testing, prophylactic administration for anaphylaxis), or immunosuppressive agents or had received such agents within 14 days before enrollment;
- Pregnant or lactating women, or patients of childbearing age who refused contraception during the study period;
- Investigators believe that the patient has any other conditions that are not suitable for participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 210000
Xiaohui Zhai, 862038285497, zhaixh@mail.sysu.edu.cn
Yanhong Deng
About this study
Official title: Fruquintinib Combined With Tislelizumab and FOLFOX as First-Line Treatment For Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Open-label, Phase Ib/II Clinical Study
This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
- Conditions
- Gastric (Stomach) Cancer, Gastric Adenocarcinoma, Fruquintinib, PD-1 Inhibitor, Tislelizumab, GEJ Adenocarcinoma
- Being tested
- fruquintinib + tislelizumab + FOLFOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruquintinib + tislelizumab + FOLFOXDrug
phase Ib: fruquintinib (3+3 dose escalation design): L1: 3 mg/d, L2: 4 mg/d, L3: 5 mg/d, qd po, D1-14, Q3W; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin : 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W.
phase II: fruquintinib: RP2D; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin: 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W.
| Study group | Role | What they receive |
|---|---|---|
| fruquintinib + tislelizumab + FOLFOX | Experimental | fruquintinib + tislelizumab + FOLFOX Receives: Drug: fruquintinib + tislelizumab + FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Maximum tolerated dose (MTD)
Maximum Tolerated Dose (MTD) of fruquintinib. Investigators leading the study will find the maximum tolerated dose by assessing the rate of serious side effects (known as "dose limiting toxicities") among participants according to the CTCAE 5.0.
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase Ib: RD
To determine the recommended phase 2 dose of fruquintinib, according to the dose limiting toxicities (DLTs).
Measured: At the end of Cycle 1 (each cycle is 21 days)
Six-month progression-free survival
The proportion of patients who remain alive and free from disease progression for at least 6 months after initiating treatment.
Measured: At six months
Secondary outcomes (4)
PFS
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Measured: Up to 3 years
OS
OS is defined as the time from the date of randomization to the date of death due to any cause.
Measured: Up to 3 years
ORR
ORR is defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) per RESISTv1.1.
Measured: Up to 3 years
DCR
DCR is defined as the percentage of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD) per RESISTv1.1.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric (Stomach) CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871527
- Sponsor's protocol ID
- 2025ZSLYEC-081
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib Combined With Tislelizumab and FOLFOX as First-Line Treatment For Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Open-label, Phase Ib/II Clinical Study
- ClinicalTrials.gov ID
- NCT06871527
- Acronym / sponsor ID
- 2025ZSLYEC-081
- Conditions
- Gastric (Stomach) Cancer, Gastric Adenocarcinoma, Fruquintinib, PD-1 Inhibitor, Tislelizumab, GEJ Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fruquintinib + tislelizumab + FOLFOX | Experimental | Drug: fruquintinib + tislelizumab + FOLFOXfruquintinib + tislelizumab + FOLFOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18-75 years old (including 18 and 75 years old);
- Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
- Pathologically determined gastric or gastroesophageal junction adenocarcinoma;
- Advanced patients with radiographic confirmation of inoperable complete resection;
- No previous anti-tumor treatment for metastatic diseases;
Key exclusion criteria (17 listed)
- Patients who had received any drug in the study protocol in the last year;
- Deficient mismatch repair (dMMR) or MSI-H detected by genetic test;
- HER2 positive（HER-2 3+, or HER-2 2+ and FISH+）;
- Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
- Patients with acute coronary syndromes (including myocardial infarction and unstable angina) received coronary angioplasty or stenting within 6 months before enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fruquintinib + tislelizumab + FOLFOXphase Ib: fruquintinib (3+3 dose escalation design): L1: 3 mg/d, L2: 4 mg/d, L3: 5 mg/d, qd po, D1-14, Q3W; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin : 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W. phase II: fruquintinib: RP2D; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin: 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W. | Drug | fruquintinib + tislelizumab + FOLFOX |
Primary outcome
Phase Ib: Maximum tolerated dose (MTD)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Maximum Tolerated Dose (MTD) of fruquintinib. Investigators leading the study will find the maximum tolerated dose by assessing the rate of serious side effects (known as "dose limiting toxicities") among participants according to the CTCAE 5.0.
Phase Ib: RD
Time frame: At the end of Cycle 1 (each cycle is 21 days)
To determine the recommended phase 2 dose of fruquintinib, according to the dose limiting toxicities (DLTs).
Six-month progression-free survival
Time frame: At six months
The proportion of patients who remain alive and free from disease progression for at least 6 months after initiating treatment.
4 secondary outcomes
PFS
Time frame: Up to 3 years
OS
Time frame: Up to 3 years
ORR
Time frame: Up to 3 years
DCR
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fruquintinib + tislelizumab + FOLFOX in people with Gastric (Stomach) Cancer and Gastric Adenocarcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site 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 11 inclusion and 17 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaohui Zhai (862038285497, zhaixh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Maximum tolerated dose (MTD) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2025.