Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer

NCT05640609 | Recruiting Phase 1

• 1 other identifier: 250260270
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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.

  1.5-3months

• 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.

  2years

Secondary Outcomes (3)

• progression-free survival（PFS）

  1-2years

• overall survival (OS)

  1-3years

• disease control rate (DCR)

  1-3years

Study Arms (1)

Capeox regimen combined with Sintilimab and Bevacizumab

EXPERIMENTAL

Capeox regimen combined with Sintilimab and Bevacizumab

Combination Product: Capeox regimen combined with Sintilimab and Bevacizumab

Interventions

Capeox regimen combined with Sintilimab and Bevacizumab COMBINATION_PRODUCT

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

Capeox regimen combined with Sintilimab and Bevacizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Liu Ming

Chengdu, China

RECRUITING

Related Publications (20)

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• Rini BI, Powles T, Atkins MB, Escudier B, McDermott DF, Suarez C, Bracarda S, Stadler WM, Donskov F, Lee JL, Hawkins R, Ravaud A, Alekseev B, Staehler M, Uemura M, De Giorgi U, Mellado B, Porta C, Melichar B, Gurney H, Bedke J, Choueiri TK, Parnis F, Khaznadar T, Thobhani A, Li S, Piault-Louis E, Frantz G, Huseni M, Schiff C, Green MC, Motzer RJ; IMmotion151 Study Group. Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial. Lancet. 2019 Jun 15;393(10189):2404-2415. doi: 10.1016/S0140-6736(19)30723-8. Epub 2019 May 9.

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  PMID: 26884585 RESULT

• Dai R, Zhang P, Cheng M, Bi F, Zhou J, Liu M. CapeOX (capecitabine and oxaliplatin) combined with sintilimab and bevacizumab biosimilar (IBI305) for first-line treatment of advanced gastric or oesophagogastric junction adenocarcinoma: study protocol for a single-arm, phase Ib/II trial. BMJ Open. 2026 Jan 9;16(1):e086005. doi: 10.1136/bmjopen-2024-086005.

  PMID: 41513419 DERIVED

Related Links

• ESMO

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; Bevacizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Liu Ming, Professor

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Liu Ming, Professor

CONTACT

+86 18980606324; liuming629@wchscu.cn

Dai Ruihong, doctor

CONTACT

+86 18715779637; 760173632@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: December 7, 2022
• Study Start: March 10, 2023
• Primary Completion: November 1, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

CN (1)