Conversion Therapy of Disitamab Vedotin Combined With Sintilimab and S-1 in HER2 Overexpression Gastric Cancer

November 17, 2022 updated by: Tianjin Medical University Cancer Institute and Hospital

Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Sintilimab and S-1 in the Conversion Treatment of HER2 Overexpression Unresectable Gastric Cancer

This is a phase II, one-arm study, which is aiming to evaluate the feasibility of combination of Disitamab Vedotin, Sintilimab and S-1 as conversion therapy in patients with HER2 overexpression unresectable gastric cancer .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, 30 HER2 overexpression unresectable gastric cancer patients will enrolle and treate with Disitamab Vedotin, Sintilimab and S-1. During the study period, imaging examinations were conducted every 6-12 weeks to evaluate the tumor and whether it reached the operable standard. The scheme and duration of postoperative adjuvant treatment were determined by the investigator according to the patient's conditions (Sintilimab was recommended to be maintained for 1 year, and other drugs were increased or decreased according to the patient's conditions). During the study, safety evaluation and effectiveness evaluation will be conducted.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1) Volunteer to take part in the study ;
  • 2) Age 18~70 (including 70), male or female;
  • 3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
  • 4) Has a single initial unresectable factor. For example, peritoneal metastasis (P1),Intraperitoneal free cancer cells positive (CY1), Paraaortic lymph node metastasis, liver metastasis (≤ 3 lesions, and ≤ 5 cm for a single lesion), ovarian metastasis;
  • 5) Have not received systematic treatment;
  • 6) The HER2 immunohistochemistry (IHC) test result is IHC 3+or 2+, and the previous test results of the subject (confirmed by the investigator) are acceptable;
  • 7) At least one assessable lesion (RECIST 1.1 );
  • 8) Expected survival time ≥ 6 months;
  • 9) ECOG 0-1;
  • 10) Major organs are functioning normally；

Exclusion Criteria:

  • 1) Have a history of malignant tumors other than gastric cancer, except for the following two cases:

    1. The patient has received possible curative treatment and there is no evidence of the disease within 5 years;
    2. The resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ were successfully received;
  • 2) Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.);
  • 3) Have received allogeneic stem cells or solid organ transplantation in the past;
  • 4) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and have been less than 4 weeks from the completion of treatment to the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1 (except hair loss and pigmentation);
  • 5) Previous or current congenital or acquired immunodeficiency disease;
  • 6) Active or previously recorded autoimmune diseases or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilators, etc.), vitiligo or asthma that has completely alleviated in childhood, Those who do not need any intervention after adulthood can be included;

  • 7) Systemic immunosuppressive drugs were used within 2 weeks before enrollment, or were expected to be required during the study, except for the following:

    d) Corticosteroids for intranasal, inhalation, external or local injection (such as intra-articular injection);

    e) The dose of prednisone or other equivalent systemic corticosteroids does not exceed 10 mg/day;

    f) Preventive use of corticosteroids for hypersensitivity;

  • 8) Allergic to the study drug;
  • 9) Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;
  • 10) Patients at risk for severe bleeding；
  • 11) Cardiovascular diseases with significant clinical significance;
  • 12) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation;
  • 13) Serious infection in active period or poorly controlled clinically;
  • 14) Not recovered from the operation;
  • 15) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
  • 16) Other situations that the investigator thinks are not suitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Disitamab Vedotin Combined With Sintilimab and S-1
30 HER2 overexpression unresectable gastric cancer patients will enrolle and treate with Disitamab Vedotin, Sintilimab and S-1. During the study period, imaging examinations were conducted every 6-12 weeks to evaluate the tumor and whether it reached the operable standard. The scheme and duration of postoperative adjuvant treatment were determined by the investigator according to the patient's conditions (Sintilimab was recommended to be maintained for 1 year, and other drugs were increased or decreased according to the patient's conditions).
Drug: Disitamab Vedotin
2.5mg/kg，IV，Q3W
Other Names:
  • RC48
Drug: Sintilimab
200 mg，IV，Q3W
Other Names:
  • TYVYT
Drug: S-1
40~60mg / m2, bid, d1-14, repeated every 3 weeks.
Other Names:
  • Tegafur，Gimeracil and Oteracil Potassium Capsules
Procedure: Intraperitoneal chemotherapy with paclitaxel
Paclitaxel (PTX) was used with a dose of 60mg / m2, Q3W. （Only for patients with peritoneal metastases）
Other Names:
  • Paclitaxel (PTX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: 1 year
The proportion of patients who underwent R0 surgery among all patients.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate (ORR)
Time Frame: up to one year
The proportion of patients who achieved patial response and complete reponse per RECIST version 1.1.
up to one year
overall survival (OS)
Time Frame: From the first dose to death from any cause, up to two years.
median OS or OS rate
From the first dose to death from any cause, up to two years.
Recurrence free survival（RFS）
Time Frame: From the first dose to recurrence or death from any cause, up to two years.
median RFS or RFS rate
From the first dose to recurrence or death from any cause, up to two years.
safety profile
Time Frame: up to 30 days after last treatment administration
The grade and proportion of adverse events, treatment related adverse events, immune-related adverse events (irAEs), serious adverse events, and perioperative complications, etc.
up to 30 days after last treatment administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: Han Liang, Master, ianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

November 17, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 25, 2022

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E20221046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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