An Exploratory Study of Immunotherapy Combined With Anlotinib and Chemotherapy in Perioperative Treatment of LAGC

NCT05800080 | Unknown

• 1 other identifier: AK104-IIT-C-W-0031
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

• 1\. Main objective: to evaluate the pathological complete response (pCR) of gastric cancer after local advanced COVID-19 infection by two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy.
• 2\. Secondary objective: to evaluate the major pathological response (MPR), disease-free survival (DFS), objective response rate (ORR), R0 resection rate (R0 resection rate) and safety of two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy for gastric cancer after local advanced COVID-19 infection。

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• The pathological complete response;

  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 (2)

Single immunotherapy group；

EXPERIMENTAL

one group receives peri operative treatment of Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy；

Drug: Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy

Double immune treatment group

EXPERIMENTAL

one group receives peri operative treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy

Drug: Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy

Interventions

Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy DRUG

one group receives peri operative treatment of Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy, and the other group receives peri operative treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy.After receiving corresponding neoadjuvant treatment for 3 cycles according to the established treatment plan, surgical treatment shall be carried out within 3-6 weeks after drug withdrawal

Also known as: Teggio, Oxaliplatin

Double immune treatment group; Single immunotherapy group；

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 confirmed by pathology (histology or cytology) (according to WHO classification in 2015);
• Nucleic acid test or antigen test to identify patients with COVID-19 infection
• According to the TNM stage of clinical tumor in the 8th edition, T3\~4N+M0 gastric cancer patients confirmed as resectable or potentially resectable by endoscopic ultrasound and enhanced CT;
• It has 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;);
• Those who were diagnosed as gastric cancer for the first time before enrollment and did not undergo radiotherapy, chemotherapy, surgery and targeted treatment;
• The function of main organs is normal, that is, they meet the following standards:
• The blood routine examination must meet the following requirements (no blood transfusion, no hemopoietic factor and no drug correction within 14 days):
• ANC ≥ 1.5 × 109/L；
• PLT ≥ 100 × 109/L；
• HB ≥ 90 g/L；
• Biochemical examination shall meet the following standards:
• TBIL≤1.5 × ULN；
• ALT、AST≤ 2.5 × ULN

You may not qualify if:

• Patients with distant metastasis;
• Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibodies;
• Medical history and complications
• Other malignant tumors in the past 3 years;
• Have any history of active autoimmune diseases or autoimmune diseases (including 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 after adulthood; Patients who need bronchodilator for medical intervention cannot be included;
• Immunosuppressive drugs were used within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or systemic steroid hormones with physiological dose (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 the best drug treatment);
• Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; Arrhythmias (including QTcF: male ≥ 450 ms, female ≥ 470 ms) require long-term use of antiarrhythmic drugs and cardiac insufficiency of New York Heart Association grade ≥ II; Or uncontrolled heart failure;
• There is evidence that there is pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia and serious damage to lung function in the past or at present;
• Severe infection (such as the need for intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown cause occurred during screening/before the first administration\>38.5 ° C;
• There is clinically significant hemoptysis (more than 50 mL of hemoptysis per day) within the first three months of the study, or there is clinically obvious bleeding symptom or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood++or above the baseline, or suffering from vasculitis).
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Inoculate live attenuated vaccine within 4 weeks before the first administration or during the study period;
• Physical examination and laboratory examination findings
• People with congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method) or combined with hepatitis B and hepatitis C infection;

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

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

+86-13709284513; hongliu1@fmmu.edu.cn

Wei Zhou

CONTACT

0086-13709284513; 252376698@qq.com

Study Design

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

Model Details: one group receives peri operative treatment of Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy, and the other group receives peri operative treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy Penpulimab (single immunity, fixed dose 200mg) orCadonilimab (double immunity, fixed dose 500mg), which will be administered on the first day of each cycle and repeated every three weeks; Anlotinib Hydrochloride Capsules: 12mg, administered on the 1-14th day of each cycle Other Names: Teggio Oxaliplatin

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: April 5, 2023
• Study Start: April 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2025
• Last Updated: April 5, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)