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

May 10, 2025 updated by: Queling Liu

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Have fully understood this study and voluntarily signed the informed consent form;
  2. Be at least 18 years old, regardless of gender;
  3. 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);
  4. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
  5. Have an expected survival of ≥ 12 weeks;
  6. Have at least one measurable lesion (according to RECIST 1.1);
  7. 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.

Exclusion Criteria:

  1. Have previously received treatment with VEGF or VEGFR inhibitors;
  2. Have received live vaccines within 4 weeks before enrollment or are likely to receive them during the study period;
  3. Have had an autoimmune disease or a history of autoimmune disease within 4 weeks before enrollment;
  4. Have previously received allogeneic bone marrow transplantation or organ transplantation;
  5. 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;
  6. 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);

  7. 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%;
  8. 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);
  9. Have uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture as judged by the researcher);
  10. 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);
  11. Have urine routine indicating proteinuria ≥ 2+ and 24-hour urinary protein quantification > 1.0g;
  12. 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;
  13. Have active bleeding or a bleeding tendency;
  14. Have diseases or conditions that affect the absorption of the drug currently, or be unable to take fruquintinib orally;
  15. Have experienced allergic reactions to fruquintinib and/or the excipients in the test drug;
  16. Be considered by the researcher as unsuitable for enrollment in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fruquintinib Combined with Sintilimab and Stereotactic Body Radiation Therapy
Drug: Fruquintinib Combined with Sintilimab and Stereotactic Body Radiation Therapy
no other intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queling Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

May 10, 2025

First Posted (Actual)

May 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IITI2024099

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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