Gastric CancerPhase 2NCT05720533

Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With Gastric Cancer

A Phase 2 study testing Disitamab Vedotin Combined With Sintilimab in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This study aims to explore the safety and efficacy of Disitamab vedotin combined with Sintilimab in elderly patients with HER2 overexpression Gastric Cancer. This is a single-arm exploratory clinical study. 20 patients with eHER2 overexpression gastric cancer are scheduled to be enrolled. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Gastric Cancer
What is being tested?: Disitamab Vedotin Combined With Sintilimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: 1 Mar 2023to 1 Mar 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

1) Volunteer to take part in the study ;
2) Age ≥65 , male or female;
3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
4) Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early gastric cancer and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered.
5) 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;
6) At least one assessable lesion (RECIST 1.1 );

Show all 23Show fewer

7) Expected survival time ≥ 6 months;
8) ECOG 0-2;
9) If the main organs function normally, they meet the following standards:
Blood routine examination (no blood transfusion and G-CSF use within 14 days before screening):
Hemoglobin ≥ 90 g/L;
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L；
White blood cell count ≥ 3.0 × 109/L；
Platelet count ≥ 80 × 109/L；
Blood biochemical examination (albumin was not used within 14 days before screening):
Albumin ≥ 28 g/L;
Total bilirubin ≤ 2 × Upper limit of normal value (ULN);
In the absence of liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 × ULN； ALT, AST and ALP ≤ 5× ULN in case of liver metastasis ；
Alkaline phosphatase (ALP) ≤ 5 × ULN；
Creatinine ≤ 1.5 × ULN； Or the creatinine clearance rate (CrCl) calculated by Cockcroft Gault formula is ≥ 50 mL/min;
Coagulation function:
International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN；
Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN。

Who cannot join

1) 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;
2) Have received allogeneic stem cells or solid organ transplantation in the past;
3) 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);
4) Previous or current congenital or acquired immunodeficiency disease;

Show all 12Show fewer

5) Allergic to the study drug;
6) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation;
7) Serious infection in active period or poorly controlled clinically;
8) Not recovered from the operation;
9) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
10) Other situations that the investigator thinks are not suitable for inclusion.

Trial locations and contacts

No sites are listed yet.

Zhansheng Jiang, Doctor contact

13512035574

zhjiang@tmu.edu.cn

About this study

Official title: Safety and Efficacy of Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With HER2 Overexpression Gastric Cancer

Read the detailed description

The primary objective of this study was to explore the safety and median PFS of Disitamab vedotin combined with Sintilimab as first-line treatment in elderly patients with HER2 overexpression Gastric Cancer.The secondary objective of this study was to evaluate the ORR, DCR, DOR and OS of Disitamab vedotin combined with Sintilimab as first-line treatment in elderly patients with HER2 overexpression Gastric Cancer.To provide a better treatment plan for elderly patients with Gastric Cancer.

Conditions: Gastric Cancer
Being tested: Disitamab Vedotin Combined With Sintilimab
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Disitamab Vedotin Combined With SintilimabDrug
Also called Combined treatment group
Disitamab Vedotin injection：2.5mg/kg，IV，Q3W Sintilimab injection：200mg，IV, Q3W

Study groups in NCT05720533
Study group	Role	What they receive
Disitamab Vedotin Combined With Sintilimab	Experimental	Treatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death. Receives: Drug: Disitamab Vedotin Combined With Sintilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

PFS (Progression-Free-Survival)
The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.
Measured: 24 months

Secondary outcomes (5)

ORR（Objective Response Rate）
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Measured: 24 months
DCR（Disease control rate）
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Measured: 24 months
DOR（Duration of response）
DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time.
Measured: 24 months
OS (Overall survival time)
The time of death from all causes for all patients from the date of randomization.
Measured: 24 months
The Adverse Events
AEs are any adverse medical events that occur in a subject or clinical subject and is not necessarily causally related to the treatment. Safety assessment in this study was conducted by the investigator in accordance with the definition of CTCAE 5.0.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20231 Mar 2025

First posted9 Feb 2023
Study start1 Mar 2023 (estimated)
Primary completion1 Mar 2024 (estimated)
Study completion1 Mar 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05720533
Sponsor's protocol ID: E20221383
Status last verified: Jan 2023
First submitted: 31 Jan 2023
Last updated: 9 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With HER2 Overexpression Gastric Cancer
ClinicalTrials.gov ID: NCT05720533
Acronym / sponsor ID: E20221383
Conditions: Gastric Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
Study start: 1 Mar 2023 (estimated)
Primary completion: 1 Mar 2024 (estimated)
Study completion: 1 Mar 2025 (estimated)
First posted: 9 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Disitamab Vedotin Combined With Sintilimab	Experimental	Drug: Disitamab Vedotin Combined With SintilimabTreatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (23 listed)

1) Volunteer to take part in the study ;
2) Age ≥65 , male or female;
3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
4) Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early gastric cancer and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered.
5) 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;

Key exclusion criteria (12 listed)

1) Have a history of malignant tumors other than gastric cancer, except for the following two cases:
2) Have received allogeneic stem cells or solid organ transplantation in the past;
3) 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);
4) Previous or current congenital or acquired immunodeficiency disease;
5) Allergic to the study drug;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Disitamab Vedotin Combined With SintilimabAlso: Combined treatment groupDisitamab Vedotin injection：2.5mg/kg，IV，Q3W Sintilimab injection：200mg，IV, Q3W	Drug	Disitamab Vedotin Combined With Sintilimab

Primary outcome

PFS (Progression-Free-Survival)
Time frame: 24 months
The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.

5 secondary outcomes

ORR（Objective Response Rate）
Time frame: 24 months
DCR（Disease control rate）
Time frame: 24 months
DOR（Duration of response）
Time frame: 24 months
OS (Overall survival time)
Time frame: 24 months
The Adverse Events
Time frame: 24 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Individual participant dataSharing planned: No

Related trials for Gastric Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhansheng Jiang, Doctor contact

13512035574

zhjiang@tmu.edu.cn

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Disitamab Vedotin Combined With Sintilimab in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhansheng Jiang, Doctor (13512035574, zhjiang@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (Progression-Free-Survival) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05720533.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.