Immune Combined Targeted and Chemotherapy in Perioperative Treatment of Locally Advanced Gastric Cancer

NCT05385900 | Unknown

• 1 other identifier: TQXB-GC-II-002
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

An exploratory study of pembrolizumab combined with anlotinib and chemotherapy in the perioperative treatment of locally advanced gastric cancer

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response, pCR

  Defined as tumor tissue specimens resected surgically after neoadjuvant therapy with no residual tumor cells.

  12months

Secondary Outcomes (1)

• major pathologic response, MPR

  12months

Study Arms (1)

Penpulimab in combination with anlotinib and chemotherapy

EXPERIMENTAL

After receiving the corresponding neoadjuvant therapy for 3 cycles according to the established treatment plan, surgery should be performed within 3-6 weeks after drug withdrawal.

Drug: Penpulimab combination with anlotinib and chemotherapy

Interventions

Penpulimab combination with anlotinib and chemotherapy DRUG

Penpulimab: fixed dose of 200 mg, administered on day 1 of each cycle, repeated every 3 weeks; Anlotinib: 12 mg, administered on days 1-14 of each cycle, orally once a day, about half an hour before breakfast (the time of daily administration should be the same as possible), with warm water, every 3 weeks Repeat 1 time

Also known as: Teggio, Oxaliplatin

Penpulimab in combination with anlotinib and 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:

• years old ≤ age ≤ 70 years old, male or female;
• ECOG score 0\~1 points;
• Patients with locally advanced gastric cancer (according to WHO 2015 classification) confirmed by pathology (histology or cytology);
• According to the eighth edition of clinical tumor TNM staging, patients with T3\~4N+M0 gastric cancer confirmed by endoscopic ultrasonography and enhanced CT examination as resectable or potentially resectable;
• With measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of tumor lesions is ≥10mm, and the short diameter of CT scan of lymph node lesions is ≥15mm;), tumor diameter \> 2cm;
• Those who were diagnosed with gastric cancer for the first time before enrolling in the group and who have not undergone radiotherapy, chemotherapy, surgery and targeted therapy;
• Major organ function is normal, that is, the following criteria are met:
• Routine blood tests must meet (no blood transfusion, no hematopoietic factor and no drug 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 creatinines Cr≤1.5×ULN，endogenous creatinine clearance≥50 mL/min（Cockcroft-Gault formula）；

You may not qualify if:

• Patients with distant metastasis;
• Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibody therapy;
• Medical history and comorbidities
• Suffering from other malignant tumors in the past 3 years;
• Suffering from any active autoimmune disease or history of autoimmune disease (as follows, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, Hypothyroidism (may be included after hormone replacement therapy); patients with vitiligo or complete remission of childhood asthma who do not require any intervention in adulthood may be included; patients requiring medical intervention with bronchodilators are not included;
• The use of immunosuppressive drugs within 14 days before the first use of the study drug, excluding nasal and inhaled corticosteroids or systemic steroids at physiological doses (ie, 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 therapy);
• Patients with newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; arrhythmia (including QTcF: ≥450 ms for males, ≥470 ms for females) requires long-term use of antiarrhythmic drugs and New York Cardiac Association classification ≥ class II cardiac insufficiency; or uncontrolled heart failure;
• There is evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severely impaired lung function;
• Complicated severe infection within 4 weeks before the first dose (eg: need for intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever \>38.5°C during the screening period/before the first dose;
• Clinically significant hemoptysis (more than 50 mL of 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 baseline, or suffering from vasculitis, etc.).
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Administer live attenuated vaccines within 4 weeks before the first dose or during the study period;
• Physical examination and laboratory findings
• Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (positive hepatitis C antibody, and high HCV-RNA) (the lower limit of detection of the analytical method) or co-infection with hepatitis B and C;

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

anlotinib; Drug Therapy; Oxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Coordination Complexes; Organic Chemicals

Study Officials

• Liu Hong

  Air Force Military Medical University, China

  STUDY CHAIR

Central Study Contacts

Liu Hong

CONTACT

13709284513; hongliu1@fmmu.edu.cn

Wei Zhou

CONTACT

13720542643; 252376698@qq.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

Model Details: Penpulimab in combination with anlotinib and chemotherapy

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 23, 2022
• Study Start: June 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: May 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share