Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.

NCT06155383 | Recruiting Phase 2

• 1 other identifier: RC48-C022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Conditions

Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Keywords

HER2-expressing; gastric cancer; gastroesophageal junction adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  Proportion of patients with pCR. pCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes (ypT0N0)

  Up to approximately 2 years

Secondary Outcomes (7)

• Objective remission rate (ORR)

  Up to approximately 2 years

• R0 resection rate

  Up to approximately 2 years

• Tumor regression grade (TRG) score

  Up to approximately 2 years

• Major pathological response (MPR)

  Up to approximately 2 years

• Event free survival (EFS)

  Up to approximately 2 years

Study Arms (3)

XELOX (capecitabine + oxaliplatin)

ACTIVE COMPARATOR

capecitabine with oxaliplatin arm

Drug: Capecitabine; Drug: oxaliplatin

Disitamab Vedotin + Toripalimab

EXPERIMENTAL

Disitamab Vedotin with Toripalimab arm

Drug: Disitamab Vedotin; Drug: Toripalimab

Disitamab Vedotin + Toripalimab + XELOX

EXPERIMENTAL

Disitamab Vedotin + Toripalimab + XELOX arm

Drug: Capecitabine; Drug: oxaliplatin; Drug: Disitamab Vedotin; Drug: Toripalimab

Interventions

Capecitabine DRUG

1000 mg/m2, Bid orally, D1-14, every 3 weeks

Disitamab Vedotin + Toripalimab + XELOX; XELOX (capecitabine + oxaliplatin)

oxaliplatin DRUG

130 mg/m2, intravenous infusion, D1, every 3 weeks

Disitamab Vedotin + Toripalimab + XELOX; XELOX (capecitabine + oxaliplatin)

Disitamab Vedotin DRUG

2.5 mg/kg, intravenous infusion, D1, every 2 weeks

Also known as: RC48

Disitamab Vedotin + Toripalimab; Disitamab Vedotin + Toripalimab + XELOX

Toripalimab DRUG

3.0 mg/kg, intravenous infusion, D1, every 2 weeks

Also known as: JS001

Disitamab Vedotin + Toripalimab; Disitamab Vedotin + Toripalimab + XELOX

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate and sign the informed consent form;
• Male or female, ≥18 years;
• Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology;
• Clinical stage cT3-4aN+, no distant metastasis (M0);
• According to the baseline imaging and medical history data evaluated by the Investigators, radical surgery for gastric cancer and R0 resection is expected; Subjects had not previously received any antitumor therapy for gastric or gastroesophageal junction adenocarcinoma;
• HER2- expression: IHC 1+, 2+, 3+;
• ECOG performance status score of 0 or 1;
• Cardiac function: left ventricular ejection fraction ≥50%;
• The following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial center):
• Bone marrow function:
• absolute neutrophil count (ANC) ≥1.5×109/L (no treatment with granulocyte colony-stimulating factor within 1 week prior to examination);
• Platelets ≥100×109/L (platelets should not be transfused within 1 week before the examination, and recombinant human thrombopoietin therapy should not be used within 2 weeks)
• hemoglobin ≥9g/dL (blood transfusion and erythropoietin treatment are not allowed within 2 weeks prior to the examination);
• Liver function:
• Serum total bilirubin ≤1.5 times the upper limit of normal (ULN);

You may not qualify if:

• Received any anti-tumor therapy for gastric or gastroesophageal junction adenocarcinoma before study dosing, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and other anti-tumor drug therapy (including Chinese medicine treatment with anti-tumor ingredients specified in the instructions within 2 weeks before screening);
• The investigators considered perioperative period treatment of patients requiring radiotherapy for target lesions；
• Major surgery was performed within 4 weeks before the start of study dosing and did not fully recover;
• Patients with active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening;
• Gastrointestinal perforation/fistula 6 months before screening;
• Upper digestive tract obstruction that cannot guarantee drug absorption, functional abnormalities or malabsorption syndrome, which can affect the absorption of capecitabine ;
• Peripheral polyneuropathy ≥ NCI Ⅱ grade；
• Serum virology examination (based on the normal value of the research center):
• Positive HBsAg test with positive HBV DNA copy number;
• Positive HCVAb test with positive HCV RNA PCR test.
• Positive HIVAb test.
• Have received live vaccine within 4 weeks prior to screening or plan to receive any vaccine during the study period (except for the novel coronavirus vaccine);
• Heart failure rated 3 or higher by the New York College of Cardiology (NYHA);
• Cardiac chest pain, defined as moderate pain that restricts daily activities, occurred within 28 days prior to screening. There were serious arteriovenous thrombosis events or cardiovascular and cerebrovascular accidents within six months before dosing, such as deep vein thrombosis (except asymptomatic and untreated intermuscular venous thrombosis), pulmonary embolism, cerebral infarction, cerebral hemorrhage, and myocardial infarction (except asymptomatic lacunar infarction that did not require clinical intervention);
• There is an active or advanced infection that requires systematic treatment (experimental medication may be initiated 2 weeks after the end of anti-infective therapy), such as active tuberculosis;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (11)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100042, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

Yunnan Cancer Hospital

Kunming, Fujian, China

NOT YET RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

NOT YET RECRUITING

Gansu Wuwei Tumour Hospital

Wuwei, Gansu, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

Shandong Cancer Hospital & Institute

Jinan, Shangdong, China

NOT YET RECRUITING

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Oxaliplatin; disitamab vedotin; toripalimab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Jianmin Fang, Ph.D

  RemeGen Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Jianmin Fang, Ph.D

CONTACT

+8610-58075763; Jianminfang@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: November 27, 2023
• Primary Completion: January 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)