A Phase Ib/II Trial of Capeox Regimen Combined With Sintilimab and Bevacizumab in First-line Treatment for Recurrent or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
Led by West China Hospital · Updated on 2023-05-16
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104 weeks
Total Duration
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What this Trial Is About
Researchers are studying advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction, focusing on patients who have not yet received systemic treatment. The study evaluates the combination of the Capeox chemotherapy regimen with the immunotherapy drug sintilimab and the targeted therapy bevacizumab. This phase Ib/II clinical trial aims to explore the safety, appropriate dose, and response rate of this combination as a first-line treatment for recurrent or metastatic gastric cancer, addressing the current limitations of standard chemotherapy whose median survival time is about one year.
The treatment involves two stages: Stage Ib includes oxaliplatin, capecitabine tablets, sintilimab, and bevacizumab; Stage II uses bevacizumab at a dose determined in Stage Ib, while the other drugs continue at the same dosage. Participants receive this combination therapy without a comparison group since it is a one-arm, open-label study. The study also assesses the best dose of bevacizumab and monitors treatment response and disease control over time.
Participants will undergo regular evaluations including imaging to measure lesion response, laboratory tests to check organ function and blood counts, and pregnancy testing for females of childbearing age. The main outcomes measured are the appropriate bevacizumab dose within 1.5 to 3 months and the objective response rate over two years. Secondary outcomes include progression-free survival, overall survival, and disease control rate monitored between one and three years. The total duration of participation varies, and patients are monitored closely for safety and treatment effects throughout the study.
CONDITIONS
Brief Title
Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
Histological or cytological diagnosis of adenocarcinoma of stomach or gastroesophageal junction including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma
Unresectable recurrent or metastatic disease confirmed by imaging and surgical evaluation
Expected survival time greater than 3 months
Age between 18 and 70 years, any gender
No prior systemic treatment for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
If prior adjuvant or neoadjuvant therapy was given, it must have been completed at least 6 months before study entry without recurrence or progression
Palliative radiotherapy allowed if completed at least 2 weeks before treatment
Eastern Cooperative Oncology Group (ECoG) performance status of 1
At least one measurable lesion per RECIST 1.1 criteria
Ability to provide pathological tissue samples within 6 months prior to consent for screening
Normal main organ function based on blood and biochemical tests as defined in the criteria
Acute toxicity from previous treatments resolved to grade 0-1 or as specified
Negative pregnancy test for women of childbearing potential and agreement to use effective contraception
Willingness and ability to follow study visits and procedures with informed consent
You will not qualify if you...
Known positive HER2 status
Gastric cancer types other than adenocarcinoma or mixed with other tissue types
Uncontrolled or symptomatic active central nervous system metastases
Uncontrolled pleural effusion or ascites, or symptomatic pericardial effusion
Weight loss exceeding 20% in the two months prior to randomization
Major surgery within 28 days before randomization (except biopsy or catheter insertion)
Use of immunosuppressive drugs within 7 days before randomization, except certain corticosteroids
Live attenuated vaccine within 28 days before randomization or 60 days after treatment
Antineoplastic therapy within 28 days before randomization
Other malignancies diagnosed within 3 years except certain treated cancers
Active autoimmune diseases requiring systemic immunosuppression
Prior treatment with anti-PD-1/PD-L1 or anti-CTLA-4 antibodies
Significant bleeding or thrombotic events within specified timeframes
Major vascular disease within 6 months before treatment
Severe wounds, ulcers, or untreated fractures
Peripheral neuropathy greater than grade 1
Current or recent symptoms of ileus
Interstitial lung disease or uncontrolled systemic diseases
Known allergy to study drugs or severe reactions to monoclonal antibodies
HIV infection or AIDS
Untreated active hepatitis B or C infections
Recent serious cardiovascular events or poorly controlled hypertension
Recent systemic antibiotic use or fever of unknown origin
History of allogeneic organ or stem cell transplantation
Participation in another drug trial within 4 weeks or 5 half-lives of last drug
History of substance abuse
Other serious laboratory abnormalities or illnesses increasing study risk or interfering with results
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1.5 to 3 months for dose determination, up to 2 years for treatment response evaluation
Participants receive the Capeox chemotherapy regimen combined with Sintilimab and Bevacizumab as first-line treatment for recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma.
Regular visits during treatment cycles (frequency as per protocol)
Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a biomarker evaluation from the AVAGAST randomized phase III trial.
Lower exposure and faster clearance of bevacizumab in gastric cancer and the impact of patient variables: analysis of individual data from AVAGAST phase III trial.
First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial.
Yelena Y Janjigian, Kohei Shitara, Markus Moehler...
Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial.
Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer: The KEYNOTE-062 Phase 3 Randomized Clinical Trial.
Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study.
Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial.
