Gastric NeoplasmPhase 2/3NCT06977061
Efficacy and Safety of Fruquintinib Combined With Sintilimab and Stereotactic Body Radiation Therapy (SBRT) for the Second-line and Higher-line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Oligometastatic Progression
A Phase 2/3 study testing Fruquintinib Combined with Sintilimab and Stereotactic Body Radiation Therapy in people with Gastric Neoplasm, run by Queling Liu.
Trial summary
Efficacy and safety of fruquintinib in combination with sintilizumab and SBRT in the treatment of oligonadenocarcinoma progression in the stomach or gastroesophageal junction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Neoplasm
- What is being tested?
- Fruquintinib Combined with Sintilimab and Stereotactic Body Radiation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Sep 2026
- Phase
- Phase 2/3
- 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
- Have fully understood this study and voluntarily signed the informed consent form;
- Be at least 18 years old, regardless of gender;
- Have histologically and/or cytologically confirmed metastatic or locally advanced gastric or gastroesophageal junction adenocarcinoma, and have experienced at least one failure of systemic treatment (Note: The previously accepted systemic treatment regimens in this protocol include chemotherapy alone or in combination with multiple drugs, or immunotherapy combined with chemotherapy, or failure after receiving anti-HER-2 targeted therapy for HER-2 positive cases. Failure is defined as intolerable toxic side effects, disease progression during treatment, or recurrence after the end of treatment);
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Have an expected survival of ≥ 12 weeks;
- Have at least one measurable lesion (according to RECIST 1.1);
- Have normal major organ functions, meeting the following criteria:
- 1.Blood routine examination: Hemoglobin (Hb) ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L; White blood cell count (WBC) ≥ 3.0×10⁹/L; 2.Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× the upper limit of normal (ULN) (for patients with liver metastasis, ≤ 5×ULN); Serum total bilirubin (TBIL) ≤ 1.5×ULN (for subjects with Gilbert's syndrome, ≤ 3×ULN; for patients with liver metastasis, total bilirubin ≤ 3×ULN); Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate ≥ 50ml/min; 3.Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5×ULN; 4.Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%; 8.For subjects with potential fertility, they need to use at least one medically approved contraceptive measure (such as an intrauterine device, contraceptive pills, or condoms) during the study treatment period and within 180 days after the end of the study treatment; and the serum/urine human chorionic gonadotropin (HCG) test must be negative before the first administration; and they must not be lactating.
Who cannot join
- Have previously received treatment with VEGF or VEGFR inhibitors;
- Have received live vaccines within 4 weeks before enrollment or are likely to receive them during the study period;
- Have had an autoimmune disease or a history of autoimmune disease within 4 weeks before enrollment;
- Have previously received allogeneic bone marrow transplantation or organ transplantation;
- Have had another malignant tumor within 5 years before enrollment, except for skin basal cell carcinoma or squamous cell carcinoma after radical resection, or cervical carcinoma in situ;
- Have symptomatic or active central nervous system (CNS) metastases or carcinomatous meningitis (patients with asymptomatic or stable brain metastases after treatment are allowed to be included);
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- Have a history of severe cardiovascular and cerebrovascular diseases:
- Have experienced cerebrovascular accident (excluding lacunar infarction, mild cerebral ischemia or transient ischemic attack, etc.) within 6 months before the first administration of the study drug, myocardial infarction, unstable angina pectoris, uncontrolled arrhythmia (including QTc interval ≥ 450ms for men and ≥ 470 ms for women) (QTc interval is calculated using the Fridericia formula);
- Have a New York Heart Association (NYHA) cardiac function classification > grade II or a left ventricular ejection fraction (LVEF) < 50%;
- Have clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or hepatitis C (for a history of hepatitis B virus infection, regardless of drug control, hepatitis B virus DNA ≥ 1×10⁴ copies/mL or > 2000 IU/ml);
- Have uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture as judged by the researcher);
- Have uncontrolled hypertension that cannot be controlled by drugs currently, defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg (except for patients whose blood pressure can be controlled by dual-drug antihypertensive treatment before enrollment);
- Have urine routine indicating proteinuria ≥ 2+ and 24-hour urinary protein quantification > 1.0g;
- Have active ulcers in the stomach and duodenum, digestive tract diseases such as ulcerative colitis, or active bleeding in unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the researcher;
- Have active bleeding or a bleeding tendency;
- Have diseases or conditions that affect the absorption of the drug currently, or be unable to take fruquintinib orally;
- Have experienced allergic reactions to fruquintinib and/or the excipients in the test drug;
- Be considered by the researcher as unsuitable for enrollment in this study.
About this study
Official title: A Single-Arm, Open-Label Phase II Clinical Study of Fruquintinib Combined With Sintilimab and Stereotactic Body Radiation Therapy (SBRT) for the Second-Line and Higher-Line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Oligometastatic Progression
Efficacy and safety of fruquintinib in combination with sintilizumab and SBRT in the treatment of oligonadenocarcinoma progression in the stomach or gastroesophageal junction
Read the detailed description
To explore the efficacy and safety of the combination of fruquintinib, sintilimab and SBRT for the treatment of gastric or gastroesophageal junction adenocarcinoma with oligometastatic progression in the second-line and higher-line settings, with the aim of improving the clinical treatment outcomes for patients with gastric or gastroesophageal junction adenocarcinoma.
- Conditions
- Gastric Neoplasm
- Being tested
- Fruquintinib Combined with Sintilimab and Stereotactic Body Radiation Therapy
- 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 Combined with Sintilimab and Stereotactic Body Radiation TherapyDrug
no other intervention
| Study group | Role | What they receive |
|---|---|---|
| Fruquintinib Combined with Sintilimab and Stereotactic Body Radiation Therapy | Experimental | Not described Receives: Drug: Fruquintinib Combined with Sintilimab and Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric NeoplasmStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queling Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Queling Liu, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977061
- Sponsor's protocol ID
- IITI2024099
- Status last verified
- Mar 2025
- First submitted
- 30 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Phase II Clinical Study of Fruquintinib Combined With Sintilimab and Stereotactic Body Radiation Therapy (SBRT) for the Second-Line and Higher-Line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Oligometastatic Progression
- ClinicalTrials.gov ID
- NCT06977061
- Acronym / sponsor ID
- IITI2024099
- Conditions
- Gastric Neoplasm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queling LiuUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 16 May 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.
Efficacy and safety of fruquintinib in combination with sintilizumab and SBRT in the treatment of oligonadenocarcinoma progression in the stomach or gastroesophageal junction
Detailed description
To explore the efficacy and safety of the combination of fruquintinib, sintilimab and SBRT for the treatment of gastric or gastroesophageal junction adenocarcinoma with oligometastatic progression in the second-line and higher-line settings, with the aim of improving the clinical treatment outcomes for patients with gastric or gastroesophageal junction 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 Combined with Sintilimab and Stereotactic Body Radiation Therapy | Experimental | Drug: Fruquintinib Combined with Sintilimab and Stereotactic Body Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have fully understood this study and voluntarily signed the informed consent form;
- Be at least 18 years old, regardless of gender;
- Have histologically and/or cytologically confirmed metastatic or locally advanced gastric or gastroesophageal junction adenocarcinoma, and have experienced at least one failure of systemic treatment (Note: The previously accepted systemic treatment regimens in this protocol include chemotherapy alone or in combination with multiple drugs, or immunotherapy combined with chemotherapy, or failure after receiving anti-HER-2 targeted therapy for HER-2 positive cases. Failure is defined as intolerable toxic side effects, disease progression during treatment, or recurrence after the end of treatment);
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Have an expected survival of ≥ 12 weeks;
Key exclusion criteria (18 listed)
- Have previously received treatment with VEGF or VEGFR inhibitors;
- Have received live vaccines within 4 weeks before enrollment or are likely to receive them during the study period;
- Have had an autoimmune disease or a history of autoimmune disease within 4 weeks before enrollment;
- Have previously received allogeneic bone marrow transplantation or organ transplantation;
- Have had another malignant tumor within 5 years before enrollment, except for skin basal cell carcinoma or squamous cell carcinoma after radical resection, or cervical carcinoma in situ;
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 Combined with Sintilimab and Stereotactic Body Radiation Therapyno other intervention | Drug | Fruquintinib Combined with Sintilimab and Stereotactic Body Radiation Therapy |
Primary outcome
Progression-free survival (PFS)
Time frame: 6 weeks
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 16 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fruquintinib Combined with Sintilimab and Stereotactic Body Radiation Therapy in people with Gastric Neoplasm, run by Queling Liu.
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 18 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
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?
Progression-free survival (PFS) (time frame: 6 weeks). 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 16 May 2025.