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
Qualifiers
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
Treatments tested in this trial
- Fruquintinib in combination with Sintilimab and CAPEOX
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov