NCT05640609
Recruiting
Phase 1
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
ConditionsStomach Neoplasm
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- West China Hospital
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- the appropriate dose of Bevacizumab
Overview
Brief Summary
The median survival time of first-line chemotherapy for advanced gastric cancer is about one year, and the treatment is still facing the bottleneck. This is a one-arm, open and prospective phase II clinical study. Recruit patients who have been diagnosed with advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction and have not received systematic treatment.
Detailed Description
The median survival time of first-line chemotherapy for advanced gastric cancer is about one year, and the treatment is still facing the bottleneck. Bevacizumab is an anti-vascular endothelial growth factor (VEGF) targeted therapy drug. It is doubtful whether the low dose of bevacizumab in gastric cancer patients leads to poor curative effect. Now the treatment of advanced gastric cancer has come to the era of immunotherapy. The chemotherapy regimen of daclizumab combined with CAPEOX has been proved to be effective in clinical studies. No clinical study has confirmed the safety and efficacy of CAPEOX regimen combined with sintilimab and bevacizumab.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histological or cytological diagnosis confirmed adenocarcinoma of stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma)
- •Imaging and surgical evaluation of unresectable recurrent or metastatic patients
- •The expected survival time was more than 3 months
- •The age is between 18 and 70 years old, both male and female
- •No systematic treatment has been given to patients with advanced or metastatic gastric and esophagogastric junction adenocarcinoma.If the patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy and chemotherapy), the last treatment must be completed at least 6 months before randomization, and there is no recurrence or disease progression at the time of treatment.Palliative radiotherapy was allowed, but it must be completed at least 2 weeks before the first study treatment.Subjects were allowed to receive anti-tumor traditional Chinese medicine preparations in the past, but they must be discontinued at least 2 weeks before randomization
- •Eastern Cooperative Oncology Group(ECoG) - 1 physical status
- •At least one lesion can be evaluated according to RECIST 1.1 criteria
- •It can provide pathological tissues or fresh pathological tissues that are filed within 6 months after the signature of informed consent for screening, and can obtain the test results. For the slices filed within 6 months before randomization, it should be confirmed that no systematic treatment (including adjuvant / neoadjuvant therapy) has been received after obtaining the samples
- •The function of the main organs is normal, that is to say, it meets the following standards:
- •Blood routine examination (no blood transfusion within 14 days before screening)
Exclusion Criteria
- •HER2 + (or HER2 +) is known to be positive
- •Gastric cancer known as squamous cell carcinoma, undifferentiated or other tissue types, or adenocarcinoma mixed with other tissue types
- •There are uncontrolled or symptomatic active central nervous system (CNS) metastases, which can be characterized by clinical symptoms, brain edema, spinal cord compression, cancer metastasis, malignant meningitis, leptomeningeal disease, and / or progressive growth.Patients with CNS metastases can be enrolled in the study if they are adequately treated and their psychiatric symptoms can return to baseline level at least 2 weeks before randomization (except for residual signs or symptoms related to CNS treatment).In addition, subjects were required to discontinue corticosteroids or receive prednisone (or equivalent other corticosteroids) at least 2 weeks before randomization, or to receive a stable or gradually reduced dose of prednisone (or equivalent) at least 2 weeks before randomization
- •There were hydrothorax and ascites which could not be controlled by puncture and drainage within 14 days before the random;Pericardial effusion with clinical symptoms or moderate or above
- •The weight of the subjects decreased by more than 20% in the first two months of randomization
- •The following treatments or drugs were received before randomization: a) major surgery was performed within 28 days before randomization (tissue biopsy and peripherally inserted central catheter operation peripherally inserted central venous catheter （PICC） for diagnosis are allowed; b) immunosuppressive drugs were used within 7 days before randomization,Does not include nasal and inhaled corticosteroids or physiological doses of systemic hormones (i.e. no more than 10 mg / D of nisone or other corticosteroids with equivalent physiologic doses);c) Live attenuated vaccine was administered within 28 days before randomization or within 60 days after the end of drug treatment;d) Antineoplastic therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biotherapy or tumor embolization) within 28 days before randomization
- •Any other malignant tumor was diagnosed within 3 years before entering the study, except basal cell carcinoma of skin or squamous or superficial bladder cancer, carcinoma in situ of cervix, intraductal carcinoma of breast and papillary thyroid carcinoma that can be treated locally and cured.
- •There is any active, known or suspected autoimmune disease.Subjects who were in a stable state and did not need systemic immunosuppressive therapy were allowed to be included, such as type I diabetes mellitus, hypothyroid diabetes mellitus requiring hormone replacement therapy only, and skin diseases without systemic treatment (e.g., vitiligo, psoriasis and alopecia)
- •Previously received anti-PD-1 / PD-L1 antibody, anti-CTLA-4 antibody or other drugs acting on T-cell co stimulation or examination cell co stimulation or checkpoint pathway
- •There were significant bleeding symptoms or bleeding tendency in 3 months before random;Gastrointestinal perforation and / or gastrointestinal fistula occurred within 6 months before randomization;Arteriovenous thrombosis events occurred in the first 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc
Outcomes
Primary Outcomes
the appropriate dose of Bevacizumab
Time Frame: 1.5-3months
According to the incidence of dose-limited toxic dose -limiting toxicity (DLT) after 2 and 4 cycles of Ib phase treatment, the appropriate dose of Bevacizumab combination was determined.
the objective Response Rate (ORR) of the experimental group.
Time Frame: 2years
The main purpose of phase II is the objective Response Rate (ORR) of the experimental group.
Secondary Outcomes
- overall survival (OS)(1-3years)
- disease control rate (DCR)(1-3years)
- progression-free survival（PFS）(1-2years)
Investigators
Ming Liu
Associate Professor
West China Hospital
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Irinotecan Versus Only Best Supportive Care for Gastric CancerStomach NeoplasmNeoplasm MetastasisNCT00144378Charite University, Berlin, Germany44
Completed
Phase 2
Chemotherapy Combined With Apatinib and PD-1 AntibodyGastric CancerNCT05025033Tianjin Medical University Cancer Institute and Hospital30
Terminated
Phase 2
Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction CarcinomaGastric CarcinomaGastroesophageal Junction CarcinomaNCT00256321University of California, Irvine4
Withdrawn
Phase 1
Feasibility of Autologous Tumor Cell-TLR9 Agonist Vaccination for Metastatic Colorectal CancerColorectal NeoplasmsAnal, Colon, and Rectal CancersNCT00780988Stanford University
Completed
Phase 2
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System LymphomaLymphoma, Non-HodgkinHIV InfectionsNCT00000801National Institute of Allergy and Infectious Diseases (NIAID)33