A Multi-center, Phase II Study to Evaluate Efficacy and Safety of Perioperative Chemotherapy With Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel (FLOT) and Trastuzumab in Combination With Toripalimab in Patients With HER2 Positive Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative chemotherapy with FLOT regimen and trastuzumab in combination with toripalimab in participants with resectable HER2 positive locally advanced gastric or esophagogastric junction adenocarcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).

⁃ The gender is not limited. Age: ≥ 18 years and ≤ 80 years old.

⁃ Gastric or esophagogastric junction adenocarcinoma confirmed by pathology.

⁃ HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by fluorescent in situ hybridization (FISH) based on pretreatment endoscopic biopsies.

⁃ Clinical stage at presentation: cT2-T4b, N+/-, M0 as determined by AJCC staging system, 8th edition.

∙ The definition of metastatic lymph nodes: a lymph node must be ≥ 10mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm) according to the guideline of Response Evaluation Criteria in Solid Tumours (RECIST version 1.1)

⁃ Participants with a performance status of 0 \

• 1 on the Eastern Cooperative Oncology Group (ECOG) within 7 days before the first dose of study treatment.

⁃ Life expectancy ≥ 6 months.

⁃ Agreement of providing pretreatment endoscopic biopsies specimens and surgical specimens for biomarker analysis, as well as the peripheral blood, feces and urine sample.

⁃ The functions of the vital organs meet requirements as follow (within 14 days before the first dose of study treatment, participant has not received treatment of recombinant human thrombopoietin or granulocyte stimulating factor):

• Hematological function:

‣ White blood cell count (WBC): 3.5 × 10 \^ 9 / L \

‣ 0 × 10 \^ 9 / L;

⁃ Absolute neutrophil count (ANC) ≥ 1.5 × 10 \^ 9 / L;

⁃ Platelet count (PLT) ≥ 100 × 10 \^ 9 / L;

⁃ Hemoglobin (Hb) ≥ 90 g / L.

∙ Hepatic function:

‣ Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal);

⁃ Aspartate aminotransferase (AST) ≤ 2.5 × ULN;

⁃ Alanine aminotransferase (ALT) ≤ 2.5 × ULN;

⁃ Albumin (ALB) ≥ 30 g / L.

∙ Renal function:

‣ Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml / min for those with creatinine level \> 1.5 × ULN.

∙ Coagulation function:

‣ International normalized ratio (INR) ≤ 1.5;

⁃ Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

∙ Cardiac function:

‣ The left ventricular ejection fraction (LVEF) value ≥ 55 %, as assessed by echocardiography

⁃ Female of childbearing age must meet requirements: urine or serum pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toriplimab, or 210 days after the last dose of trastuzumab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding. For the male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toriplimab, or 210 days after the last dose of trastuzumab, or 180 days after the last dose of chemotherapy, whichever is longer).

Locations
Other Locations
China
The First Affiliated Hospital, College of Medicine, Zhejiang University
RECRUITING
Hangzhou
The Second Affiliated Hospital, College of Medicine, Zhejiang University
NOT_YET_RECRUITING
Hangzhou
Huzhou Central Hospital
NOT_YET_RECRUITING
Huzhou
Lishui Central Hospital
NOT_YET_RECRUITING
Lishui
Ningbo First Hospital
NOT_YET_RECRUITING
Ningbo
Ningbo Medical Center LiHuiLi Hospital
NOT_YET_RECRUITING
Ningbo
Ningbo Second Hospital
NOT_YET_RECRUITING
Ningbo
Taizhou Hospital
NOT_YET_RECRUITING
Taizhou
Contact Information
Primary
Jiren Yu
yujr0909@zju.edu.cn
0086-0571-87237931
Time Frame
Start Date: 2023-02-28
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 30
Treatments
Experimental: Toripalimab plus Trastuzumab with FLOT(5-FU+leucovorin+docetaxel+oxaliplatin)
Related Therapeutic Areas
Sponsors
Leads: Yu jiren

This content was sourced from clinicaltrials.gov

Similar Clinical Trials