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Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer

Primary Purpose

Stomach Neoplasm

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Capeox regimen combined with Sintilimab and Bevacizumab
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) Hemoglobin ≥ 90 g / L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 75×109/L; Blood biochemical test (albumin was not used within 14 days before screening) Albumin ≥ 28 g / L; Total bilirubin ≤ 1.5×Upper limit of normal value (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3×ULN; If there is liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 5×ULN Creatinine ≤ 1.5×ULN;Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN; Activated partial thromboplastin time (APTT) ≤ 1.5×ULN For sections filed in the first 6 months of randomization, it should be confirmed that no systematic treatment (including adjuvant / neoadjuvant therapy) has been received since sample acquisition Acute toxicity caused by previous anti-tumor treatment or surgery was relieved to grade 0-1 (according to ncictcae 5.0) or to the level specified in the inclusion / exclusion criteria Female subjects of childbearing age were required to conduct a serum pregnancy test within 3 days before the start of the study, and the results were negative, and they were willing to use a medically recognized high-efficiency contraceptive method (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study drug;For male subjects whose partners are women of childbearing age, they should be sterilized by surgery or agree to use effective contraceptive methods during the study and within 3 months after the last study administration With my consent and signed the letter of understanding, I am willing and able to follow the planned visit, research treatment, laboratory examination and other test procedures 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 Major vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral artery thrombosis) within 6 months before the start of study treatment Severe, unhealed or dehiscent wounds and active ulcers or untreated fractures There were peripheral neuropathy > 1 grade If the symptoms of ileus (ileus) at the beginning of the study (with or without complete parenteral nutrition treatment) and symptoms of ileus were resolved at the time of initial diagnosis or complete parenteral nutrition treatment, or if the patient did not have the symptoms of ileus at the time of initial diagnosis / treatment, or had not received complete parenteral nutrition treatment,Patients may be admitted to the study Interstitial lung disease, non infectious inflammation or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia, etc.) Known allergy to the study drug or any of its excipients, or severe allergic reactions to other monoclonal antibodies Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) Untreated active hepatitis B was defined as HBV-DNA ≥ 500 IU / ml;Hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method;Or combined with hepatitis B and C co infection In the first 6 months, the following conditions occurred: myocardial infarction, severe / unstable angina pectoris, New York Heart Association (NYHA )grade 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure Hypertension was poorly controlled by drug therapy (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) Systemic use of antibiotics for more than 7 days in 4 weeks before randomization, or fever of unknown origin > 38.5 ° C during screening period / before first administration (fever due to tumor can be included in the group according to the judgment of the researcher) Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation Participated in any other drug clinical study within 4 weeks before randomization, or no more than 5 half-life from the last study A history of psychotropic substance abuse or abuse is known The presence of other laboratory abnormalities with severe physical or mental illness may increase the risk of participating in the study, or interfere with the results of the study and patients considered unsuitable for the study

Sites / Locations

  • Liu MingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capeox regimen combined with Sintilimab and Bevacizumab

Arm Description

Capeox regimen combined with Sintilimab and Bevacizumab

Outcomes

Primary Outcome Measures

the appropriate dose of Bevacizumab
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.
The main purpose of phase II is the objective Response Rate (ORR) of the experimental group.

Secondary Outcome Measures

progression-free survival(PFS)
Refers to the time between the patient's admission to the treatment and the disease progression
overall survival (OS)
Refers to the time from admission to treatment to death of patients
disease control rate (DCR)
Refers to the proportion of people who receive this program in the whole patient population and achieve complete response ,partial response or stable disease and last for a period of time

Full Information

First Posted
November 13, 2022
Last Updated
May 12, 2023
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05640609
Brief Title
Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capeox regimen combined with Sintilimab and Bevacizumab
Arm Type
Experimental
Arm Description
Capeox regimen combined with Sintilimab and Bevacizumab
Intervention Type
Combination Product
Intervention Name(s)
Capeox regimen combined with Sintilimab and Bevacizumab
Intervention Description
Stage Ib:Oxaliplatin +Capecitabine Tablets +Sintilimab +Bevacizumab Stage II:Bevacizumab (the dose determined in phase Ib clinical study),the dosage of other drugs was the same as before
Primary Outcome Measure Information:
Title
the appropriate dose of Bevacizumab
Description
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.
Time Frame
1.5-3months
Title
the objective Response Rate (ORR) of the experimental group.
Description
The main purpose of phase II is the objective Response Rate (ORR) of the experimental group.
Time Frame
2years
Secondary Outcome Measure Information:
Title
progression-free survival(PFS)
Description
Refers to the time between the patient's admission to the treatment and the disease progression
Time Frame
1-2years
Title
overall survival (OS)
Description
Refers to the time from admission to treatment to death of patients
Time Frame
1-3years
Title
disease control rate (DCR)
Description
Refers to the proportion of people who receive this program in the whole patient population and achieve complete response ,partial response or stable disease and last for a period of time
Time Frame
1-3years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) Hemoglobin ≥ 90 g / L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 75×109/L; Blood biochemical test (albumin was not used within 14 days before screening) Albumin ≥ 28 g / L; Total bilirubin ≤ 1.5×Upper limit of normal value (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3×ULN; If there is liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 5×ULN Creatinine ≤ 1.5×ULN;Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN; Activated partial thromboplastin time (APTT) ≤ 1.5×ULN For sections filed in the first 6 months of randomization, it should be confirmed that no systematic treatment (including adjuvant / neoadjuvant therapy) has been received since sample acquisition Acute toxicity caused by previous anti-tumor treatment or surgery was relieved to grade 0-1 (according to ncictcae 5.0) or to the level specified in the inclusion / exclusion criteria Female subjects of childbearing age were required to conduct a serum pregnancy test within 3 days before the start of the study, and the results were negative, and they were willing to use a medically recognized high-efficiency contraceptive method (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study drug;For male subjects whose partners are women of childbearing age, they should be sterilized by surgery or agree to use effective contraceptive methods during the study and within 3 months after the last study administration With my consent and signed the letter of understanding, I am willing and able to follow the planned visit, research treatment, laboratory examination and other test procedures 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 Major vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral artery thrombosis) within 6 months before the start of study treatment Severe, unhealed or dehiscent wounds and active ulcers or untreated fractures There were peripheral neuropathy > 1 grade If the symptoms of ileus (ileus) at the beginning of the study (with or without complete parenteral nutrition treatment) and symptoms of ileus were resolved at the time of initial diagnosis or complete parenteral nutrition treatment, or if the patient did not have the symptoms of ileus at the time of initial diagnosis / treatment, or had not received complete parenteral nutrition treatment,Patients may be admitted to the study Interstitial lung disease, non infectious inflammation or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia, etc.) Known allergy to the study drug or any of its excipients, or severe allergic reactions to other monoclonal antibodies Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS) Untreated active hepatitis B was defined as HBV-DNA ≥ 500 IU / ml;Hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method;Or combined with hepatitis B and C co infection In the first 6 months, the following conditions occurred: myocardial infarction, severe / unstable angina pectoris, New York Heart Association (NYHA )grade 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure Hypertension was poorly controlled by drug therapy (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg) Systemic use of antibiotics for more than 7 days in 4 weeks before randomization, or fever of unknown origin > 38.5 ° C during screening period / before first administration (fever due to tumor can be included in the group according to the judgment of the researcher) Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation Participated in any other drug clinical study within 4 weeks before randomization, or no more than 5 half-life from the last study A history of psychotropic substance abuse or abuse is known The presence of other laboratory abnormalities with severe physical or mental illness may increase the risk of participating in the study, or interfere with the results of the study and patients considered unsuitable for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Ming, Professor
Phone
+86 18980606324
Email
liuming629@wchscu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Dai Ruihong, doctor
Phone
+86 18715779637
Email
760173632@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Ming, Professor
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Liu Ming
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Ming, Ph.D/MD
Phone
+86 18980606324
Email
liuming629@wchscu.cn
First Name & Middle Initial & Last Name & Degree
Dai Ruihong
Phone
18715779637
Email
760173632@qq.com

12. IPD Sharing Statement

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Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer

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