Efficacy and Safety of Disitamab Vedotin Combined With Sintilimab

NCT05928897 | Unknown Phase 2 DMC

• 1 other identifier: 202208181
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Efficacy and Safety of Disitamab Vedotin Combined With Sintilimab in Second-line Treatment of Advanced Gastric Cancer: a Prospective, Single Arm Clinical Study

Conditions

Gastric Cancer

Keywords

Gastric Cancer, Her-2, ADC

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate

  1 year

Secondary Outcomes (2)

• PFS

  2 years

• OS

  2 years

Study Arms (1)

Disitamab Vedotin Combined With Sintilimab

EXPERIMENTAL

Disitamab Vedotin (2.5mg/kg, ivgtt, Q3W) Combined With Sintilimab (200mg, ivgtt, Q3W) untill diseases progress

Drug: Disitamab Vedotin combined with Sintilimab

Interventions

Disitamab Vedotin combined with Sintilimab DRUG

Disitamab Vedotin combined with Sintilimab

Also known as: RC48

Disitamab Vedotin Combined With Sintilimab

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed gastric adenocarcinoma, which is diagnosed as unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma (including signet-ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma).
• Pathological results showed that the expression of HER-2 was positive (IHC score 3+, or IHC score 2+ and ISH score positive) or low (IHC score 1+, or IHC score 2+ and ISH score negative) in gastric adenocarcinoma.
• Failed to receive first-line system medication of gastric carcinoma chemotherapy.
• Male or female, aged 18-75 years old.
• ECOG score 0-2.
• Life expectancy more than 12 weeks.
• There is at least one measurable or assessable focus (According to RECIST 1.1).
• Patients who received radical radiotherapy within 3 months before entering the study are eligible to participate in this study if the radiation area of bone marrow is less than 30%.
• The function of main organs and bone marrow function are normal, defined as follows:
• Blood test:
• White blood cell (WBC) ≥ 4.5\*103 / mm3;
• Absolute neutrophil count (ANC) ≥ 1.5\*103 / mm3;
• Blood platelet count ≥ 100\*103 / mm3;
• hemoglobin ≥ 9.0g/dL (no transfusion or erythropoietin dependence within 7 days).
• Liver function:

You may not qualify if:

• Signs of active bleeding in the focus.
• Previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other antibodies or drugs targeting T cell costimulatory or checkpoint pathways.
• Be allergic to the active ingredients or excipients of Sintilimab or disitamab vedotin;
• Participate in another interventional clinical study (except observational clinical study or follow-up phase of an intervention study) at the same time;
• Received systemic treatment with anti-tumor indications of proprietary Chinese medicine or immunomodulatory drugs (eg. thymosin/interferon/interleukin, except drugs used locally to control pleural effusion or ascites) within 2 weeks before the first dose.
• Received immunosuppressive drugs within 4 weeks before the first dose of the study, excluding nasal, inhaled or other topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., no more than 10mg/d prednisone or equivalent doses of other glucocorticoids), or the use of hormones for the prevention of contrast medium allergy.
• Live attenuated vaccine may be received within 4 weeks before the first dose of study treatment or during the study period.
• Note: inactivated injection virus vaccine for seasonal influenza is allowed.
• Surgical procedures were performed within 4 weeks before the first dose of study treatment, or major surgery was expected during the study treatment;
• Laparoscopic exploratory surgery was performed within 2 weeks before the first dose of study treatment.
• There was toxicity (excluding alopecia, non-clinically significant, and asymptomatic laboratory abnormalities) caused by previous antineoplastic therapy that did not return to Grade 0 or 1 in the NCICTCAEv5.0 before the first dose.
• Patients with symptomatic central nervous system cancer metastasis or cancerous meningitis. For previously treated patients with central nervous system cancer metastasis, if their condition is stable (there is no evidence of imaging progress at least 4 weeks before the first administration of the trial treatment, and repeated imaging tests confirm that there is no evidence of new brain metastasis or enlargement of the original brain metastasis), they can participate in the trial in the case they do not need steroid therapy within 14 days before the first dose of the trial treatment.
• Patients with ascites could be found by physical examination; Only imaging shows a small amount of ascites but no symptoms can be selected.
• Patients with moderate amount of bilateral pleural effusion, or large amount of pleural effusion on one side, or patients who have caused respiratory dysfunction and need drainage.
• Patients with bone metastasis at risk of paraplegia.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Shan Zeng, M.D.

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shan Zeng, M.D.

CONTACT

84327633; zengshan2000@csu.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: Director

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 3, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share