NCT05627414

Brief Summary

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_2 gastric-cancer

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_2 gastric-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 25, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

November 17, 2022

Last Update Submit

November 17, 2022

Conditions

Gastric Cancer

Keywords

Conversion therapyDisitamab VedotinHER2 overexpression

Outcome Measures

Primary Outcomes (1)

  • R0 resection rate

    The proportion of patients who underwent R0 surgery among all patients.

    1 year

Secondary Outcomes (4)

  • objective response rate (ORR)

    up to one year

  • overall survival (OS)

    From the first dose to death from any cause, up to two years.

  • Recurrence free survival（RFS）

    From the first dose to recurrence or death from any cause, up to two years.

  • safety profile

    up to 30 days after last treatment administration

Study Arms (1)

Disitamab Vedotin Combined With Sintilimab and S-1

EXPERIMENTAL

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 VedotinDrug: SintilimabDrug: S-1Procedure: Intraperitoneal chemotherapy with paclitaxel

Interventions

Disitamab VedotinDRUG

2.5mg/kg，IV，Q3W

Also known as: RC48
Disitamab Vedotin Combined With Sintilimab and S-1
SintilimabDRUG

200 mg，IV，Q3W

Also known as: TYVYT
Disitamab Vedotin Combined With Sintilimab and S-1
S-1DRUG

40\~60mg / m2, bid, d1-14, repeated every 3 weeks.

Also known as: Tegafur，Gimeracil and Oteracil Potassium Capsules
Disitamab Vedotin Combined With Sintilimab and S-1
Intraperitoneal chemotherapy with paclitaxelPROCEDURE

Paclitaxel (PTX) was used with a dose of 60mg / m2, Q3W. （Only for patients with peritoneal metastases）

Also known as: Paclitaxel (PTX)
Disitamab Vedotin Combined With Sintilimab and S-1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Volunteer to take part in the study ;
  • \) Age 18\~70 (including 70), male or female;
  • \) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
  • \) 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;
  • \) Have not received systematic treatment;
  • \) 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;
  • \) At least one assessable lesion (RECIST 1.1 );
  • \) Expected survival time ≥ 6 months;
  • \) ECOG 0-1;
  • \) Major organs are functioning normally；

You may not qualify if:

  • \) Have a history of malignant tumors other than gastric cancer, except for the following two cases:
  • The patient has received possible curative treatment and there is no evidence of the disease within 5 years;
  • 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;
  • \) 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.);
  • \) Have received allogeneic stem cells or solid organ transplantation in the past;
  • \) 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);
  • \) Previous or current congenital or acquired immunodeficiency disease;
  • \) 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;
  • \) 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;
  • \) Allergic to the study drug;
  • \) Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;
  • \) Patients at risk for severe bleeding；
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

disitamab vedotinsintilimabS 1 (combination)potassium oxonatePaclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Han Liang, Master

    ianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Liang, Master

CONTACT

+8602223340123tjlianghan@126.com

Xiaona Wang, Doctor

CONTACT

+8602223340123xiaonawang@hotmail.com

Study Design

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

Study Record Dates

First Submitted

November 17, 2022

First Posted

November 25, 2022

Study Start

January 1, 2023

Primary Completion

June 1, 2024

Study Completion

January 1, 2025

Last Updated

November 25, 2022

Record last verified: 2022-11