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New treatment option for Metastatic Gastroesophageal Junction Adenocarcinoma
Official title Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer
ClinicalTrials.gov ID: NCT06329973
What this study is testing
What is Fruquintinib in combination with Sintilimab and CAPEOX?
Fruquintinib in combination with Sintilimab and CAPEOX is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic gastroesophageal junction adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people 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...
- There is at least one measurable lesion according to RECIST 1.1 criteria;
- No previous treatment with VEGFR-targeting drugs or PD-1/PD-L1 monoclonal antibody. Patients who had received platinum or paclitaxel or fluorouracil...
You likely can't join if
- 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...
- 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;
- Patients with known central nervous system metastasis or history of central nervous system metastasis before screening. For patients with clinically...
- Patients with hypertension who are not well controlled by single antihypertensive medication (systolic blood pressure \> 140 mmHg, diastolic blood...
See the full eligibility criteria
Who can join
- people 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;
- No previous treatment with VEGFR-targeting drugs or PD-1/PD-L1 monoclonal antibody. Patients who had received platinum or paclitaxel or fluorouracil adjuvant chemotherapy after surgery and recurred more than 6 months...
- Physical condition score (ECOG PS score) : 0-1 score;
- Expected survival ≥3 months;
- The main organs function well;That is, the relevant check indicators within 14 days before randomization meet the following requirements: Hemoglobin ≥ 90 g/L (no transfusion within 14 days); Neutrophil count \>...
- Weight of more than 40 kg (including 40 kg), or BMI \> 18.5
- Women who are fertile must have a negative urine or serum pregnancy test within 7 days prior to randomization and must consent to use highly effective contraception during the study period and for at least 120 days...
- Men who are not sterilized must consent to use highly effective contraception during the study period and for at least 120 days after the last administration of fruquintinib and sintilimab and for at least 180 days...
What rules you out
- 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...
- 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;
- Patients with known central nervous system metastasis or history of central nervous system metastasis before screening. For patients with clinically suspected CNS metastasis, CT or MRI examination must be performed...
- Patients with hypertension who are not well controlled by single antihypertensive medication (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90mmHg); Patients with history of unstable angina pectoris...
- long-term unhealed wounds or incomplete healing fractures;
- Imaging shows that the tumor has invaded important blood vessels, or the investigator determines that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal massive...
- Patients with abnormal coagulation function and bleeding tendency (14 days before randomization must meet: INR in the normal range without the use of anticoagulants, or no clinically significant abnormalities); Patients...
- Occurrence of arteriovenous thrombosis events within 6 months prior to screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by...
- Urine routine indicated urinary protein ≥++ and confirmed 24-hour urinary protein quantity \> 1.0g;
- Have used immunotargeted therapy drugs;
- Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
- Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids;
- A history of serious chronic autoimmune diseases, such as systemic lupus erythematosus; History of ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases, irritable bowel syndrome and other chronic...
- Patients with hypersensitivity to human or murine monoclonal antibodies;
- Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
- pleural effusion or abdominal effusion with clinical symptoms requiring clinical intervention;
- Patients who do not follow medical advice, do not use drugs according to regulations, or have incomplete data that can affect the evaluation of how well it works or safety;
- In the judgment of the investigator, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.