Disitamab Vedotin Combined With Sintilimab and XELOX Perioperative Treatment for Resectable Gastric Caner With HER2 Overexpression

NCT06227325 | Unknown Phase 2

• 1 other identifier: RCVDTYPEC067
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of RC48 combined withSintilimab and chemotherapy in perioperative therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• pathological complete response (pCR) rate

  The percentage of patients with no residual cells at the primary cancer site and N(-) per histological evaluation.

  Up to approximately 12 weeks

Secondary Outcomes (6)

• R0 resection rate

  Up to approximately 12 weeks

• Disease free survival (DFS)

  From randomization to the date of recurrence or death (up to approximately 4 years).

• Major pathological response (MPR) rate

  Up to approximately 12 weeks

• Clinical downgrading rate

  Up to approximately 12 weeks

• Overall survival (OS)

  From the randomization to the date of death (up to approximately 4 years).

Study Arms (1)

treatment group

EXPERIMENTAL

Neoadjuvant therapy:RC48 combined with Sintilimab and XELOX repeat every 2 weeks or every 3 weeks for a total of 3 cycles Adjuvant therapy: RC48 combined with Sintilimab and XELOX repeat every 2 weeks or every 3 weeks for a total of 5 cycles

Drug: RC48 combined with Sintilimab and XELOX

Interventions

RC48 combined with Sintilimab and XELOX DRUG

RC48: 2.5 mg/kg, iv, d1, repeat every 2 weeks; Sintilimab: 200mg, iv, d1, repeat every 3 weeks; XELOX: Oxaliplatin 130mg/m2, iv, d1；Capecitabine1000 mg po, bid, d1-14, repeat every 3 weeks

Also known as: Disitamab vedotin combined with Sintilimab and XELOX

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects volunteered to join the study, could complete the signing of the informed consent form, and had good compliance;
• Aged at least 18-75 years, male or female;
• Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology is diagnosed as cT3-4aN1-3M0 according to AJCC version 8, and cTNM is diagnosed as cT3-4aN1-3M0 according to endoscopic ultrasonography or enhanced CT/MRI scanning (combined with ultrasonic gastroscopy and diagnostic laparoscopic exploration if necessary), and the researcher evaluates that the lesion is resectable;
• Have not received systematic treatment for current diseases in the past, including surgical treatment, anti-tumor radiochemotherapy/immunotherapy, etc;
• Patients who agree to receive radical surgical treatment and have no surgical contraindication as judged by the surgeon.
• IHC(immuno-histochemistry) results confirmed HER2 expression (defined as IHC 2+and 3+);
• ECOG (Eastern Cooperative Oncology Group) score 0-1;
• Expected life ≥ 6 months;
• The main organs function well and meet the standards:
• The fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study. The serum pregnancy test was negative within 7 days before the study was included, and they must be non lactating subjects.

You may not qualify if:

• Malignant diseases other than gastric cancer diagnosed within 5 years prior to initial administration;
• Known endoscopic signs of active bleeding;
• The subject is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing;
• Previous treatment with anti-HER2, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulus or synergistic inhibition of T cell receptors;
• Received systemic systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration;
• An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;
• Was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration;
• Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• Known allergy to the drugs used in this study;
• Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);
• Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
• Untreated active hepatitis B (defined as HBsAg positive and HBV(hepatitis B virus)-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center);
• Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
• Received live vaccine within 30 days prior to the first dose (cycle 1, day 1);
• Pregnant or lactating women;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; XELOX

Condition Hierarchy (Ancestors)

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

Study Officials

• Ying Liu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Liu

CONTACT

+86-13783604602; yaya7207@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: RC48+PD-1+chemotherapy

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 26, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 26, 2024

Record last verified: 2023-09

Locations

CN (1)