Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital
About this trial
Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects aged 18-75 years (including 18 and 75 years);
Understand the research procedure and content, and voluntarily sign a written informed consent;
Incurable advanced/recurrent gastric or gastroesophageal junction adenocarcinoma with histopathological and/or cytological confirmation of HER2-negative or HER2 status unknown;
There is at least one measurable lesion according to RECIST 1.1 criteria;
Disqualifiers
Patients with other malignant tumors in the past or at the same time, but have been cured of early tumors, including skin basal cell carcinoma, cervical carcinoma in situ, stage I lung cancer, stage I colorectal cancer and other tumors that researchers judge will not affect the patient's life in the short term can be excluded;
Participated in other drug clinical trials within four weeks;
have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
Have a history of bleeding, any bleeding event with a severity rating of CTCAE5.0 or higher occurring within 4 weeks prior to screening;
Trial design
Design model
Single group
Treatments tested in this trial
Fruquintinib in combination with Sintilimab and CAPEOX
DrugDifferent doses of fruquintinib combined with sintilimab and CAPEOX
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Fruquintinib in combination with Sintilimab and CAPEOXExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate
It refers to the proportion of patients whose tumors have shrunk to a certain extent for a certain period of time, including CR and PR cases
Time frame
From date of enrollment until the date of the end of the study, assessed up to 48 months2
Maximum tolerated dose
Refers to the maximum tolerated dose of the whole group
Time frame
Within the first 21 days of treatmentSecondary outcomes
1
Overall Survival
Refers to the date from admission to death from any cause
Time frame
From date of enrollment until the date of death, assessed up to 48 months2
Progression Free Survival
Refers to the date from admission to the first onset of disease progression or death from any cause, whichever comes first
Time frame
From date of enrollment until the date of first documented progression, assessed up to 48 months3
Disease Control Rate
Refers to the percentage of confirmed complete response, partial response, and stable disease cases in patients evaluated for efficacy
Time frame
From date of enrollment until the date of the end of the study, assessed up to 48 months4
Duration of Response
Refers to the date of first documented response (Complete Response or Partial Response) until the date of first documented disease progression or death from any cause, whichever occurs first.
Time frame
From date of enrollment until the date of the end of the study, assessed up to 48 monthsSponsors and contacts
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Source ClinicalTrials.gov