The Efficacy and Safety of Benmelstobart for GC/EGC

NCT06603974 | Not Yet Recruiting DMC

• 1 other identifier: TQXB-GC-001
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the major pathological response (MPR) rate of locally advanced gastric cancer / gastroesophageal junction cancer treated with bemosumab combined with antiangiogenic drugs and neoadjuvant chemotherapy. Researchers will use drug Benmelstobart in combination with antiangiogenesis drugs and newadjuvant chemotherapy to see if the drug works to treat locally advanced gastric cancer / gastroesophageal junction cancer. Participants will:injection drug Benmelstobart，On the first day of each cycle, 3 weeks (21 days) were a treatment cycle.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  Tumor tissue samples surgically removed after neoadjuvant therapy, without residual tumor cells

  2 years

Study Arms (1)

Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy

EXPERIMENTAL

Benmelstobart: 1200mg, diluted to 250ml with normal saline, infusion time 60 ± 10mins. The first day of each cycle, 3 weeks (21 days) as a treatment cycle; antiangiogenic drugs are decided by the investigator according to the actual situation; tegafur: it needs to be administered according to the patient's body surface area\< 40mg / time at 1.25m2; \> 50mg/ time for 1.25m2 and \<1.5m2; \> 60mg/ time at 1.5m2; Oral, twice a day, after morning and evening meals, for 14 consecutive days, rest for 7 days, as a treatment cycle; Repeat every 3 weeks; oxaliplatin: 130mg/m2, administered on the first day of each cycle, repeated every 3 weeks; Chemotherapy drugs can also be selected by the investigator. albumin paclitaxel: 260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, administered on the first and eighth days of each cycle

Procedure: surgery; Drug: Benmelstobart; Drug: tegafur; Drug: oxaliplatin; Drug: albumin paclitaxel

Interventions

surgery PROCEDURE

After receiving the corresponding neoadjuvant treatment for 2 cycles, surgery was performed within 3-6 weeks after drug withdrawal.

Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy

Benmelstobart DRUG

1200mg, diluted to 250ml with normal saline, infusion time 60 ± 10mins. The first day of each cycle, 3 weeks (21 days) as a treatment cycle

Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy

tegafur DRUG

it needs to be administered according to the patient\&#39;s body surface area\&lt; 40mg / time at 1.25m2; \&gt; 50mg/ time for 1.25m2 and \&lt;1.5m2; \&gt; 60mg/ time at 1.5m2; Oral, twice a day, after morning and evening meals, for 14 consecutive days, rest for 7 days, as a treatment cycle; Repeat every 3 weeks;

Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy

oxaliplatin DRUG

130mg/m2, administered on the first day of each cycle, repeated every 3 weeks;

Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy

albumin paclitaxel DRUG

260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, administered on the first and eighth days of each cycle

Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy

Eligibility Criteria

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

You may qualify if:

• ≤ 70 years old, male or female;
• \. ECoG score 0-1;
• \. patients with locally advanced gastric cancer / gastroesophageal junction cancer confirmed by pathology (histology or cytology) (according to the WHO classification in 2015);
• \. according to the eighth edition of clinical tumor TNM staging, patients with t3\~4n+m0 gastric cancer / gastroesophageal junction cancer confirmed to be resectable or potentially resectable by endoscopic ultrasound and enhanced CT;
• \. have measurable lesions (according to RECIST 1.1 standard, the long diameter of CT scan of tumor lesions is ≥ 10mm, and the short diameter of CT scan of lymph node lesions is ≥ 15mm;), and the tumor is \&amp;gt; 2cm directly;
• \. patients who were initially diagnosed with gastric cancer / gastroesophageal junction cancer without radiotherapy, chemotherapy, surgery and targeted therapy before enrollment;
• \. if the main organ function is normal, it meets the following criteria:
• Blood routine examination must meet the following requirements (no blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days):
• ANC ≥ 1.5 × 109/l;
• PLT ≥ 100 × 109/l;
• HB ≥ 90 g/L；
• Biochemical tests must meet the following criteria:
• TBIL ≤ 1.5 × ULN;
• Alt, AST ≤ 2.5 × ULN
• Serum creatinine SCR ≤ 1.5 × ULN, endogenous creatinine clearance ≥ 50 ml / min (Cockcroft Gault formula);

You may not qualify if:

• Patients with distant metastasis;
• Subjects who had previously received anti-PD-1 (L1) or CTLA4 mAb therapy;
• \. medical history and comorbidities
• Other malignant tumors in the past 3 years;
• Have any history of active autoimmune disease or autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); Patients with vitiligo or childhood asthma have been completely relieved and can be included without any intervention in adults; Patients who needed bronchodilators for medical intervention could not be included;
• Immunosuppressive drugs used within 14 days before the first use of study drugs, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e. no more than 10 mg/ day prednisone or its equivalent);
• Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal medical treatment);
• Patients with newly diagnosed angina within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmias (including QTCF: ≥ 450 ms for men and ≥ 470 MS for women) require long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency; Or uncontrollable heart failure;
• There is evidence that there are previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function;
• Complicated with severe infection within 4 weeks before the first administration (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or fever of unknown cause \&amp;gt;38.5 ° C during the screening period / before the first administration;
• Clinically significant hemoptysis (more than 50 ml hemoptysis per day) within 3 months before the study, or clinically significant bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood + + or above the baseline, or suffering from vasculitis, etc.).
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Live attenuated vaccine was administered within 4 weeks before the first dose or planned during the study;
• \. physical examination and laboratory examination
• Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 iu/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method), or combined hepatitis B and C co infection;

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Surgical Procedures, Operative; Tegafur; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Liu Hong, master

  Department of Digestive Surgery, Xijing Hospital, Air Force Medical University

  STUDY CHAIR

Central Study Contacts

Liu Hong, master

CONTACT

18792807591; 18792804403@163.com

Fan Yi Wu

CONTACT

18792807591; 18792804403@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): July 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09