Gastric AdenocarcinomaPhase 2NCT06888037
Fruquintinib Combined With PD-1 Inhibitor as First-line Maintenance Therapy for Advanced Gastric Cancer
A Phase 2 study testing Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX） and Maintenance treatment (after 3 months): fruquintinib+PD-1 in people with Gastric Adenocarcinoma and GEJ Adenocarcinoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This study was designed to explore the efficacy and safety of fruquintinib combined with PD-1 inhibitors as first-line maintenance therapy for advanced HER-2 Negative Gastric Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, GEJ Adenocarcinoma, First-line Therapy
- What is being tested?
- Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX） and Maintenance treatment (after 3 months): fruquintinib+PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 31 Dec 2028
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed the informed consent and had good compliance;
- Age ≥18 years, Eastern Cooperative Oncology Group (ECOG) score 0-1, and expected survival time ≥12 months;
- Histologically or cytologically unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
- He had not received previous systemic chemotherapy for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma;
- Patients with disease progression/relapse occurring more than 6 months after completion of neoadjuvant/adjuvant therapy;
- At least one measurable lesion according to RECIST version 1.1;
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- Tumor tissue/serum samples were tested as microsatellite stable (MSS) or mismatch repair intact (pMMR), HER2 negative;
- Adequate organ functions:
- Absolute neutrophil count ≥1.5×109/L; Platelet ≥100×109/L; Hemoglobin ≥90g/L; WBC≥3×109/L Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN (If liver metastasis, AST and ALT≤5 XULN)； Serum creatinine (Cr) ≤1.5XULN or serum creatinine clearance ≥50 ml/min； Urinary protein ≤2+, or 24-hour urinary protein volume ≤2000mg; Prothrombin time (PT) and partially activated prothrombin time (APTT) ≤1.5×ULN;
- Female or male patients of reproductive age must use effective contraception throughout and for 6 months after treatment.
Who cannot join
- Participated in other drug clinical trials within 4 weeks before enrollment;
- Have had other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, papillary carcinoma of the thyroid, superficial bladder, carcinoma in situ of the breast, and carcinoma in situ of the cervix ;
- History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ grade 2 (NCI-CTCAE 5.0), heart failure ≥ grade 2 New York Heart Association (NYHA), transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, etc.
- Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) and type 2 diabetes uncontrolled by antidiabetic treatment (fasting blood glucose ≥8.9mmol/L);
- Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis;
- Type 1 diabetes mellitus, hypothyroidism that can be controlled only with replacement therapy, and skin diseases (e.g., vitiligo, psoriasis) that do not require systemic treatment could be included;
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- Central nervous system (CNS) metastases that are not adequately treated, or the presence of uncontrolled or symptomatic active CNS metastases; Patients with adequately treated CNS metastases and neurologic symptoms that had returned to baseline at least 4 weeks before enrollment (with the exception of residual signs or symptoms related to CNS therapy) were eligible for enrollment; In addition, participants had to discontinue corticosteroids or to be taking a stable or tapering dose of prednisone (or equivalent doses of other corticosteroids) of 10 mg or less per day at least 4 weeks before enrollment;
- The patients had pleural effusion and ascites that could not be controlled by puncture drainage and other treatments within 14 days before enrollment. Moderate or greater pericardial effusion with clinical symptoms;
- A live or attenuated live vaccine was administered within 30 days before enrollment;
- Major surgery had been performed within 28 days before enrollment or minor nonstudy-related surgery had been performed within 7 days before enrollment (with the exception of tumor biopsy and venous-access port placement);
- Patients with clinically significant bleeding symptoms or definite bleeding tendency within 3 months before enrollment; Patients with gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment (except those whose symptoms disappeared after gastric cancer resection for bleeding/perforation of gastric cancer);
- Arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months beforeenrollment;
- Major vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral thrombosis) within 6 months before enrollment;
- Severe, unhealed or open wounds and active ulcers or untreated fractures;
- Had a history of immediate anaphylaxis;
- The presence of clinically significant pulmonary fibrosis or interstitial pneumonia as judged by the investigator; Had active lung infection prior to injection and required anti-infective therapy;
- Active infections included tuberculosis (medical history, investigator's judgment, radiological examination, and local laboratory testing), hepatitis B (hepatitis B surface antigen positive and HBV DNA above the upper limit of the study center's normal range), hepatitis C (HCV antibody positive and HVC RNA positive), HIV (HIV antibody positive), syphilis, etc;
- Had active gastrointestinal bleeding or hemoptysis;
- A history of alcohol or psychotropic substance abuse with no withdrawal or a history of mental disorder;
- Known allergy to the study drug or any of its excipients; Or severe allergic reactions to other monoclonal antibodies;
- Systemic antibiotic use for ≥ 7 days within 4 weeks before enrollment or unexplained fever >38.5°C during screening or before the first dose (fever due to a neoplastic cause, as judged by the investigator, was eligible);
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Unable to take oral medication;
- The presence of other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients who were deemed by the investigators to be unsuitable for participation 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
Ruijin Hospital
Shanghai, Shanghai Municipality, 210000
Jun Zhang, +86-21-64370045, zj10977@rjh.com.cn
About this study
Official title: A Prospective, Multicenter Clinical Study of Fruquintinib Combined With PD-1 Monoclonal Antibody as First-line Maintenance Therapy in Patients With HER-2-negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
This study was designed to explore the efficacy and safety of fruquintinib combined with PD-1 inhibitors as first-line maintenance therapy for advanced HER-2 Negative Gastric Cancer.
- Conditions
- Gastric Adenocarcinoma, GEJ Adenocarcinoma, First-line Therapy, Maintenance Therapy, Fruquintinib, PD-1
- Being tested
- Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX）, Maintenance treatment (after 3 months): fruquintinib+PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX）Drug
CAPOX/SOX (each cycle is 21 days): Oxaliplatin 130mg/m2, ivgtt, D1; Capecitabine 1000 mg/m2, po, bid, D1-14 or S-1: 40-60mg according to BSA, bid, D1-14.
FOLFOX (each cycle is 14 days): Oxaliplatin 85mg/m2, ivgtt, D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours; Leucovorin: 400mg/m2, iv, D1.
PD-1 monoclonal antibody:
Nivolumab 360mg/3 weeks or 240mg /2 weeks, iv, D1; If weight ≥60 kg, Sintilimab 200mg/3 weeks; if weight < 60 kg, Sintilimab 3mg/kg/3 weeks, iv, D1; Tislelizumab 200mg/3 weeks, iv, D1; Pembrolizumab 200mg/3 weeks, iv, D1;
Maintenance treatment (after 3 months): fruquintinib+PD-1Drug
After 3 months (12 weeks) of initial treatment with oxaliplatin-based chemotherapy combined with PD-1 monoclonal antibody, those with complete response (CR), partial response (PR) or stable disease (SD) assessed by imaging evaluation continued to receive maintenance treatment with furoquininib and PD-1 monoclonal antibody.
Fruquintinib 3 mg/d, qd po, D1-21, Q4W; PD-1 monoclonal antibody is repeated as initial treatment until the disease progresses or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Drug: fruquintinib＋PD-1 (maintenance treatment) | Experimental | Not described Receives: Drug: Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX）; Drug: Maintenance treatment (after 3 months): fruquintinib+PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year progression-free survival rate
The proportion of patients who remain alive and free from disease progression for at least 12 months after initiating treatment.
Measured: Up to 1 year
Secondary outcomes (2)
One-year overall survival rate
The proportion of patients who remain alive for at least 12 months after initiating treatment.
Measured: Up to 1 year
Two-year overall survival rate:
The proportion of patients who remain alive for at least 24 months after initiating treatment.
Measured: 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.
- First posted21 Mar 2025
- Study start31 Mar 2025 (estimated)
- Primary completion31 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 AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888037
- Sponsor's protocol ID
- HMPL-013-FLAG-G114
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study of Fruquintinib Combined With PD-1 Monoclonal Antibody as First-line Maintenance Therapy in Patients With HER-2-negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06888037
- Acronym / sponsor ID
- HMPL-013-FLAG-G114
- Conditions
- Gastric Adenocarcinoma, GEJ Adenocarcinoma, First-line Therapy, Maintenance Therapy, Fruquintinib, PD-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 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 PD-1 inhibitors as first-line maintenance therapy for advanced HER-2 Negative Gastric Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug: fruquintinib＋PD-1 (maintenance treatment) | Experimental | Drug: Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX）, Drug: Maintenance treatment (after 3 months): fruquintinib+PD-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily signed the informed consent and had good compliance;
- Age ≥18 years, Eastern Cooperative Oncology Group (ECOG) score 0-1, and expected survival time ≥12 months;
- Histologically or cytologically unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
- He had not received previous systemic chemotherapy for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma;
- Patients with disease progression/relapse occurring more than 6 months after completion of neoadjuvant/adjuvant therapy;
Key exclusion criteria (24 listed)
- Participated in other drug clinical trials within 4 weeks before enrollment;
- Have had other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, papillary carcinoma of the thyroid, superficial bladder, carcinoma in situ of the breast, and carcinoma in situ of the cervix ;
- History of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ grade 2 (NCI-CTCAE 5.0), heart failure ≥ grade 2 New York Heart Association (NYHA), transmural myocardial infarction, unstable angina, poorly controlled arrhythmia, etc.
- Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) and type 2 diabetes uncontrolled by antidiabetic treatment (fasting blood glucose ≥8.9mmol/L);
- Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis;
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 |
|---|---|---|
| Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX）CAPOX/SOX (each cycle is 21 days): Oxaliplatin 130mg/m2, ivgtt, D1; Capecitabine 1000 mg/m2, po, bid, D1-14 or S-1: 40-60mg according to BSA, bid, D1-14. FOLFOX (each cycle is 14 days): Oxaliplatin 85mg/m2, ivgtt, D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours; Leucovorin: 400mg/m2, iv, D1. PD-1 monoclonal antibody: Nivolumab 360mg/3 weeks or 240mg /2 weeks, iv, D1; If weight ≥60 kg, Sintilimab 200mg/3 weeks; if weight < 60 kg, Sintilimab 3mg/kg/3 weeks, iv, D1; Tislelizumab 200mg/3 weeks, iv, D1; Pembrolizumab 200mg/3 weeks, iv, D1; | Drug | Drug: fruquintinib＋PD-1 (maintenance treatment) |
| Maintenance treatment (after 3 months): fruquintinib+PD-1After 3 months (12 weeks) of initial treatment with oxaliplatin-based chemotherapy combined with PD-1 monoclonal antibody, those with complete response (CR), partial response (PR) or stable disease (SD) assessed by imaging evaluation continued to receive maintenance treatment with furoquininib and PD-1 monoclonal antibody. Fruquintinib 3 mg/d, qd po, D1-21, Q4W; PD-1 monoclonal antibody is repeated as initial treatment until the disease progresses or unacceptable toxicity. | Drug | Drug: fruquintinib＋PD-1 (maintenance treatment) |
Primary outcome
One-year progression-free survival rate
Time frame: Up to 1 year
The proportion of patients who remain alive and free from disease progression for at least 12 months after initiating treatment.
2 secondary outcomes
One-year overall survival rate
Time frame: Up to 1 year
Two-year overall survival rate:
Time frame: Up to 2 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 21 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 2 study testing Initial treatment: PD-1+ Oxaliplatin-based chemotherapy (CAPOX/SOX/FOLFOX） and Maintenance treatment (after 3 months): fruquintinib+PD-1 in people with Gastric Adenocarcinoma and GEJ Adenocarcinoma, run by Ruijin Hospital 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 10 inclusion and 24 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 21 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 phase mean?
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 Jun Zhang (+86-21-64370045, zj10977@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year progression-free survival rate (time frame: Up to 1 year). 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 21 Mar 2025.