Study of Perioperative Chemotherapy Combined With Tislelizumab and Trastuzumab in the Treatment of GC/EGC

NCT04819971 | Unknown Phase 2

• 1 other identifier: TIS-HER2GC-PERIOPERATIVE-IIT
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative chemotherapy improves overall survival (OS) and disease-free survival (DFS) compared with surgery alone in patients with resectable gastric adenocarcinoma (GA) or gastro-oesophageal junction adenocarcinoma (GEJA). The addition of tislelizumab and trastuzumab to chemotherapy improves outcomes in patients with HER2-positive advanced gastric cancer (GC), and the investigators aimed to explore its role in the perioperative setting.

Conditions

Stomach Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Pathological Complete Response (pCR)

  pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery.

  2 years

Secondary Outcomes (4)

• Percentage of Participants With Complete Tumor Resection (R0)

  75 days

• Percentage of Participants With Disease-free Survival (DFS)

  2 years

• Overall Survival (OS)

  2 years

• Percentage of All Participants That Discontinued Study Treatment Due to AE

  2 years

Study Arms (1)

TTC

EXPERIMENTAL

Drug: Tirelizumab; Drug: Trastuzumab; Drug: Docetaxel; Drug: S1; Drug: Oxaliplatin

Interventions

Tirelizumab DRUG

tislelizumab (intravenously, 200 mg on day 1 of every cycle for 4 preoperative and 12 postoperative cycles)

TTC

Trastuzumab DRUG

Trastuzumab(intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1 of every cycle for 4 preoperative and 12 postoperative cycles)

TTC

Docetaxel DRUG

docetaxel (intravenously, 50 mg/m2 on day 1 of every cycle for 3 preoperative cycles)

TTC

S1 DRUG

S1 (orally, 400mg/m2 BID on day 1\~14 of every cycle for 3 preoperative and 3 postoperative cycles )

TTC

Oxaliplatin DRUG

Oxaliplatin(intravenously, 100 mg /m2 on day 1 of every cycle for 3 preoperative cycles ;130mg /m2 on day 1 of every cycle for 3 postoperative cycles.

TTC

Eligibility Criteria

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

You may qualify if:

• provide archive tumor tissue samples or accept fresh tumor tissue biopsy(Sample requirements are: formalin-fixed and paraffin-embedded wax blocks of tumor tissue or at least 20 unstained tumor specimen slides).
• assessed by the surgery can be removed, histology/confirmed HER2 positive cytology and the integration of a stomach esophagus carcinoma.
• CT2-4CN any C M0 or T any CN +M0, AJCC/UICC TNM staging of gastric cancer (8th edition).
• The HER2 receptor protein status was assessed by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) using the following methods.Tumors with an IHC 3+ score are considered HER2-positive.Patients with immunohistochemical 2+ tumors were given FISH tests to determine FISH positive samples.
• Abdominal computed tomography (CT), abdominal, pelvic, and/or echo-endoscopy were performed 2 weeks before surgery to assess resectability.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.
• have no received no any anti-tumor treatment, including surgery, chemotherapy, targeted therapy, immune therapy.
• Adequate organ function (No blood transfusion or hematopoietic stimulating factor therapy was received within 14 days. Absolute neutrophil count (ANC) ≥1.5×109/L Platelet count ≥75×109/L Hemoglobin ≥80 g/L. Serum total bilirubin ≤1.5×ULN. total bilirubin must be \<3×ULN) Prothrombin time/international normalized ratio (PT/INR) ≤1.5×ULN and activated partial thromboplastin time (aPTT) ≤1.5×ULN.Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤3×ULN. For subjects with liver metastases, AST and ALT must be ≤5×ULN for subjects with liver metastases. Creatinine clearance rate (Ccr) ≥50ml/min（according to the Cockcroft-Gault formula）. Urine protein qualitative≤1+ ;Or urinary protein qualitative ≥2+, 24 hours urinary protein \< 1g)

You may not qualify if:

• A history of any other malignancy in the past 5 years (except carcinoma in situ or basal cell carcinoma of the skin or squamous cell carcinoma of the skin)
• Received other unmarketed investigational drug or therapy within 4 weeks prior to initial investigational drug use.
• A major organ surgery (excluding needle biopsy) or significant trauma occurred within 4 weeks prior to initial investigational drug use.
• Requires systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration to treat a current condition.
• Exceptions include: topical, ocular, intraarticular, intranasal, and inhaled glucocorticoids;Short-term use of glucocorticoids for preventive treatment (e.g. to prevent contrast allergy)
• Use of immunoregulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., within 14 days prior to initial use of the study drug.
• Has been administered a live vaccine within 4 weeks prior to Cycle1 Day 1.
• Previous recipient of allogeneic hematopoietic stem cell transplantation or organ transplantation.
• Previous adverse reactions to other medications have not recovered to CTCAE 5.0 level ≤1 (Other toxicities, such as hair loss, were not considered to pose a safety risk).
• Symptomatic peripheral neuropathy was evaluated as \> 2 with CTCAE 5.0.
• Has central nervous system metastases or meningeal metastases.
• Inability to swallow medications orally, or other gastrointestinal diseases (such as total intestinal obstruction, etc.) that may affect the absorption of oral medications.
• Patients who had an active infection within 1 week prior to the first use of the study drug and who currently require systemic anti-infective therapy.
• has a history of alcohol or drug abuse or dependence.
• Known history of Human Immunodeficiency Virus (HIV).

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Trastuzumab; Docetaxel; S 1 (combination); Oxaliplatin

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

feng wang, doctor

CONTACT

+8613938244776; zzuwangfeng@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 29, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (1)