Gastric CancerPhase 2NCT06560528

Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

A Phase 2 study testing combination with Disitamab Vedotin and with Tislelizumab and Capecitabine in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
What is being tested?: combination with Disitamab Vedotin and with Tislelizumab and Capecitabine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesChina
Study dates: 1 Sep 2024to 1 Sep 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1) Volunteer to take part in the study ;
2) Age 18~75 (including 75), male or female;
3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
4) Clinical stage Ⅱ, Ⅲ (cT2-4a ,N+ or -, M0, AJCC 8th);
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;

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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；

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) 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);

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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:
Corticosteroids for intranasal, inhalation, external or local injection (such as intra-articular injection);
The dose of prednisone or other equivalent systemic corticosteroids does not exceed 10 mg/day;
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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xuewei Ding, Ph.D contact

18622220158

xding@tmu.edu.cn

Han Liang, Ph.D contact

China2 sites, 2 recruiting

Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Xuewei Ding, PhD., 18622220158, xding@tmu.edu.cn
Recruiting
Xuewei Ding
Tianjin, Tianjin Municipality, 300308
Xuewei Ding, MD, 18622220158, xding@tmu.edu.cn
Recruiting

Other trials in China

About this study

Official title: Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.

Read the detailed description

This study included 40 patients with HER2 overexpression in locally advanced gastric cancer or gastroesophageal junction adenocarcinoma, who received treatment with Disitamab Vedotin combined with Tislelizumab and Capecitabine. The patient has not received any previous anti-tumor systemic therapy. HER2 expression is defined as immunohistochemistry (IHC) as 2+or 3+. Subjects who meet the inclusion criteria but do not meet the exclusion criteria will receive perioperative treatment after enrollment. Perioperative treatment includes neoadjuvant therapy and adjuvant therapy.

Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles in the neoadjuvant phase and 5 cycles of treatment in the adjuvant phase.

Conditions: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Being tested: combination with Disitamab Vedotin and with Tislelizumab and Capecitabine
Keywords: RC48-ADC, HER2
Medical subject headings: Stomach Neoplasms

What participants receive

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

combination with Disitamab Vedotin and with Tislelizumab and CapecitabineDrug
Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase.
1. Disitamab Vedotin：2.5 mg/kg，Q3W；
2. Tislelizumab：200 mg，Q3W；
3. Capecitabine：1000 mg /m2, PO, bid d1-14, Q3W.

Study groups in NCT06560528
Study group	Role	What they receive
combination with Disitamab Vedotin and with Tislelizumab and Capecitabine	Experimental	Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase. Disitamab Vedotin：2.5 mg/kg，Q3W； Tislelizumab：200 mg，Q3W； Capecitabine：1000 mg /m2, PO, bid d1-14, Q3W. Receives: Drug: combination with Disitamab Vedotin and with Tislelizumab and Capecitabine

What is being measured

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

Pathologic complete remission rate (PCR)
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.
Measured: up to 1 years

Secondary outcomes (5)

Objective response rate(ORR)
Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR
Measured: up to 3 years
Major pathological response rate (MPR)
Major pathological response (MPR) rate is defined as the proportion of participants whose percentage of residual tumor in the stomach and lymph node decreased to < 10%, as determined by a pathologist
Measured: up to 1 year
1-3-years event-free survival rate of 3year (EFS)
1-3 years event-free survival (EFS) rate is defined as proportion of participants who have no event, including disease progression, cessation of treatment for any reason, or death after 1-3 years of radical treatment.
Measured: up to 3 years
1-3 years overall survival (OS) rate
1-3 years overall survival (OS) rate is defined as proportion of participants who survived 1-3 years after radical treatment
Measured: up to 3 years
Adverse Events（AEs）
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Measured: up to 3 years

Timeline

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

1 Sep 20241 Sep 2028

First posted19 Aug 2024
Study start1 Sep 2024 (estimated)
Primary completion1 Sep 2027 (estimated)
Study completion1 Sep 2028 (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: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06560528
Sponsor's protocol ID: E20241606
Status last verified: Aug 2024
First submitted: 15 Aug 2024
Last updated: 19 Aug 2024
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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on the Efficacy and Safety of Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression
ClinicalTrials.gov ID: NCT06560528
Acronym / sponsor ID: E20241606
Conditions: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Keywords: RC48-ADC, HER2
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 40 participants (estimated)
Lead sponsor: Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
Study start: 1 Sep 2024 (estimated)
Primary completion: 1 Sep 2027 (estimated)
Study completion: 1 Sep 2028 (estimated)
First posted: 19 Aug 2024 (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.

The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.

Detailed description

Subjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles in the neoadjuvant phase and 5 cycles of treatment in the adjuvant phase.

Study design

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

Arm	Type	Receives
combination with Disitamab Vedotin and with Tislelizumab and Capecitabine	Experimental	Drug: combination with Disitamab Vedotin and with Tislelizumab and CapecitabineSubjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase. Disitamab Vedotin：2.5 mg/kg，Q3W； Tislelizumab：200 mg，Q3W； Capecitabine：1000 mg /m2, PO, bid d1-14, Q3W.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

1) Volunteer to take part in the study ;
2) Age 18~75 (including 75), male or female;
3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
4) Clinical stage Ⅱ, Ⅲ (cT2-4a ,N+ or -, M0, AJCC 8th);
5) Have not received systematic treatment;

Key exclusion criteria (21 listed)

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

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
combination with Disitamab Vedotin and with Tislelizumab and CapecitabineSubjects will receive Disitamab Vedotin combined with Tislelizumab and Capecitabine for 3 cycles (Q3W) in the neoadjuvant phase and 5 cycles (Q3W) of treatment in the adjuvant phase. 1. Disitamab Vedotin：2.5 mg/kg，Q3W； 2. Tislelizumab：200 mg，Q3W； 3. Capecitabine：1000 mg /m2, PO, bid d1-14, Q3W.	Drug	combination with Disitamab Vedotin and with Tislelizumab and Capecitabine

Primary outcome

Pathologic complete remission rate (PCR)
Time frame: up to 1 years
Pathological complete response (pCR) rate is defined as the proportion of participants whose tumor in the stomach and lymph node completely disappeared, as determined by a pathologist.

5 secondary outcomes

Objective response rate(ORR)
Time frame: up to 3 years
Major pathological response rate (MPR)
Time frame: up to 1 year
1-3-years event-free survival rate of 3year (EFS)
Time frame: up to 3 years
1-3 years overall survival (OS) rate
Time frame: up to 3 years
Adverse Events（AEs）
Time frame: up to 3 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
Individual participant dataSharing planned: No

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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.

Xuewei Ding, Ph.D contact

18622220158

xding@tmu.edu.cn

Han Liang, Ph.D contact

Han Liang, Ph.D principal investigator

Tianjin Medical University Cancer Institute and Hospital

Xuewei Ding, Ph.D principal investigator

Tianjin Medical University Cancer Institute and Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Xuewei Ding, Ph.D (18622220158, xding@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete remission rate (PCR) (time frame: up to 1 years). 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 NCT06560528.

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 19 Aug 2024.