Gastric CancerPhase 2NCT05113459

Disitamab Vedotin Combined With PD-1 and Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer（RC48-C018）

A Phase 2 study testing Disitamab Vedotin Combined With PD-1 and Neoadjuvant Chemotherapy in people with Gastric Cancer, run by Guoxin Li.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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Trial summary

This trial is a multi-center, open, single-arm, superior phase II clinical study. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Gastric Cancer
What is being tested?: Disitamab Vedotin Combined With PD-1 and Neoadjuvant Chemotherapy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: 18 Dec 2021to 18 Jun 2024
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 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Sign the informed consent form;
Age 18-75 years old (including 18 years old and 75 years old);
Expected survival period ≥ 12 weeks;
ECOG physical fitness score 0 or 1 point;
Patients with gastric cancer or gastroesophageal junction adenocarcinoma (Siewert type I-III) confirmed by histology and/or cytology, clinical stage T3-4aN+M0 (determined by the 8th edition of the AJCC staging system);
Use pre-treatment endoscopic biopsy samples for HER2 detection in the local laboratory: HER2 high expression confirmed after IHC results (defined as: IHC 2+ 3+);
Sufficient organ function:
Bone marrow function: hemoglobin ≥9g/dL; absolute neutrophil count ≥1.5×10 9/L; white blood cell count ≥3.0×10 9/L; platelet ≥100×10 9/L; Liver function: serum total bilirubin ≤1.5 times the upper limit of normal (ULN); when there is no liver metastasis, alanine aminotransferase (ALT), aspartate aminotransferase (AST and alkaline phosphatase (ALP) ≤2.5 × ULN; Renal function: blood creatinine ≤ 1.5×ULN, or creatinine clearance rate (CrCl) ≥ 60 mL/min calculated by Cockcroft-Gault formula method; Heart function: NYHA classification <3; left ventricular ejection fraction ≥50%; 8. For female subjects: women of childbearing age agree to use a medically approved contraceptive method (such as intrauterine device, contraceptives, or contraceptives) during the study treatment period and within 6 months after the end of the study treatment period for the test group participants Set), the blood pregnancy test must be negative within 7 days before the study administration (surgical sterilization or subjects aged ≥60 years can choose not to have a blood pregnancy test), and must be non-lactating; for male subjects: should For surgical sterilization, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period of the experimental group subjects; 9. Must voluntarily join this study and sign an informed consent form.

Who cannot join

Stage IV (metastatic) or unresectable gastric cancer or gastroesophageal junction adenocarcinoma (GEJ) as determined by the investigator;
Past systemic treatment for gastric cancer;
There is a history of malignant tumors in the 5 years before screening (except for gastric cancer), except for malignant tumors with negligible risk of metastasis or death (for example, 5-year OS rate> 90%), such as cervical carcinoma in situ after appropriate treatment , Non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer;
Severe cardiovascular and cerebrovascular events occurred within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage and cerebral infarction (except for lacunar infarcts that are asymptomatic and do not require treatment);
There are other lung diseases that require treatment or are serious, including but not limited to active tuberculosis, interstitial lung disease, etc.;
Are suffering from an active infection that requires systemic treatment;

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There are active autoimmune diseases that require systemic treatment in the past 2 years (such as corticosteroids or immunosuppressive drugs, etc.), and related alternative treatments (such as thyroxine, insulin, or the physiological effects of adrenal or pituitary insufficiency) are allowed Corticosteroid replacement therapy);
Major surgery other than diagnosis was received within 4 weeks before the start of study treatment, or major surgery is expected to be required during the study period
Serious infections that occurred within 4 weeks before the start of the study treatment, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia
Treat with therapeutic antibiotics within 2 weeks (intravenous antibiotics) or 5 days (oral antibiotics) before starting the study treatment
Patients who receive prophylactic antibiotics (for example, to prevent urinary tract infections or prevent exacerbations of chronic obstructive pulmonary disease) are eligible to participate in the study.
Have previously received allogeneic stem cell or solid organ transplantation;
Any other diseases, metabolic dysfunction, physical examination results or clinical laboratory results that lead to the prohibition of the use of experimental drugs, affect the interpretation of the results, put the patient at a high risk of treatment complications;
All treatments using live attenuated vaccines within 4 weeks before the start of the study treatment, or expected to be vaccinated during PD-1 treatment or within 5 months after the last PD-1 administration;
Have a clear history or current history of neurological or mental disorders, including epilepsy or dementia;
HIV test results are positive; patients with active hepatitis B or C (HBsAg positive and HBV DNA titers higher than the upper limit of normal when HBsAg is positive; HCVAb positive and HCV RNA titers higher than the upper limit of normal when HBsAg is positive);
There are factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction;
In patients who choose to receive capecitabine, it is required to use the antiviral drug solivudine (antiviral drug) or chemical structure analogs, such as brivudine. These drugs are not allowed to be used within 4 weeks before the start of study treatment including capecitabine;
Known to have hypersensitivity or delayed allergic reactions to certain components of RC48-ADC or similar drugs;
Those who are allergic to PD-1;
It is estimated that the compliance of the patient to participate in this clinical study is sufficient or the researcher thinks that there are other subjects who are not suitable to participate in this study.

Trial locations and contacts

No sites are listed yet.

liying zhao, PhD contact

hao liu, PhD contact

About this study

Official title: A Phase Ⅱ Clinical Study of Disitamab Vedotin Combined With Anti-PD-1 Antibody and Capecitabine in Neoadjuvant Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma With Moderate and High Expression of HER2

This trial is a multi-center, open, single-arm, superior phase II clinical study.

Read the detailed description

The study included 40 patients with gastric cancer or gastroesophageal junction adenocarcinoma with clinical stage T3-4aN+M0; and confirmed after HER2 IHC results Patients with medium and high expression of HER2 (defined as: IHC 2+ 3+); the neoadjuvant treatment plan is: disitamab vedotin + PD-1 + capecitabine; the main goal of the study is to explore The effectiveness of disitamab vedotin combined with PD-1 monoclonal antibody and capecitabine in the neoadjuvant treatment of locally advanced gastric or gastroesophageal junction adenocarcinoma, and ultimately provide a basis for the update of treatment decisions for locally advanced gastric or gastroesophageal junction adenocarcinoma Proof of medical evidence.

Conditions: Gastric Cancer
Being tested: Disitamab Vedotin Combined With PD-1 and Neoadjuvant Chemotherapy
Keywords: distamab vedotin PD-1
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 PD-1 and Neoadjuvant ChemotherapyDrug
disitamab vedotin：2.5mg/kg, iv,d1,q2w,6cycle PD-1(Sintilimab ):200mg,iv,d1,q2w,6cycle Capecitabine:1000mg/m2,po,bid,d1-14,q3w,4cycle

Study groups in NCT05113459
Study group	Role	What they receive
disitamab vedotin + PD-1+Capecitabine	Experimental	disitamab vedotin：2.5mg/kg,iv,d1,q2w ,6cycle PD-1: 200mg,iv,d1,q2w，6cycle Capecitabine：1000mg/m2 ,po, bid,d1-14,q3w, 4cycle Receives: Drug: Disitamab Vedotin Combined With PD-1 and Neoadjuvant Chemotherapy

What is being measured

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

pathologic Complete Response, PCR
After completion of neoadjuvant systemic therapy (NAST), hematoxylin and eosin (H\&E) assessments were performed on the completely resected gastric cancer or gastroesophageal junction adenocarcinoma sample and all sampled regional lymph nodes. No evidence of residual active tumor cells was found (currently YpT0N0 in the 8th edition of the AJCC staging system)
Measured: 3 months-6 months

Secondary outcomes (5)

Major pathologic response, MPR
Less than 10% of tumor cells were found in pathological resection specimens.
Measured: 3 months-6 months
R0 resection rate
No residue under the microscope after tumor resection
Measured: 3 months -6 months
Objective response rate, ORR
Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time after neoadjuvant treatment (mainly for solid tumors). It includes complete remission (CR, Complete Response) and partial remission (PR, Partial Response) cases
Measured: 3 months-6 months
Relapse-free survival time , RFS
The time from the start of randomization to the recurrence of the disease or the death of the patient due to disease progression.
Measured: 1-5 years
Overall survival , OS
The time from the start of randomization to death due to any cause. When the patients who were lost to follow-up before death are recorded, the time of contact with the patient is the last recorded time.
Measured: 1-5 years

Timeline

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

18 Dec 202118 Jun 2024

First posted9 Nov 2021
Study start18 Dec 2021 (estimated)
Primary completion18 Dec 2023 (estimated)
Study completion18 Jun 2024 (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.
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: NCT05113459
Sponsor's protocol ID: RC48-C018
Status last verified: Nov 2021
First submitted: 2 Nov 2021
Last updated: 9 Nov 2021
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 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ⅱ Clinical Study of Disitamab Vedotin Combined With Anti-PD-1 Antibody and Capecitabine in Neoadjuvant Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma With Moderate and High Expression of HER2
ClinicalTrials.gov ID: NCT05113459
Acronym / sponsor ID: RC48-C018
Conditions: Gastric Cancer
Keywords: distamab vedotin PD-1
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Guoxin LiUniversity, hospital or other
Study start: 18 Dec 2021 (estimated)
Primary completion: 18 Dec 2023 (estimated)
Study completion: 18 Jun 2024 (estimated)
First posted: 9 Nov 2021 (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.

This trial is a multi-center, open, single-arm, superior phase II clinical study.

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 + PD-1+Capecitabine	Experimental	Drug: Disitamab Vedotin Combined With PD-1 and Neoadjuvant Chemotherapydisitamab vedotin：2.5mg/kg,iv,d1,q2w ,6cycle PD-1: 200mg,iv,d1,q2w，6cycle Capecitabine：1000mg/m2 ,po, bid,d1-14,q3w, 4cycle

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Sign the informed consent form;
Age 18-75 years old (including 18 years old and 75 years old);
Expected survival period ≥ 12 weeks;
ECOG physical fitness score 0 or 1 point;
Patients with gastric cancer or gastroesophageal junction adenocarcinoma (Siewert type I-III) confirmed by histology and/or cytology, clinical stage T3-4aN+M0 (determined by the 8th edition of the AJCC staging system);

Key exclusion criteria (21 listed)

Stage IV (metastatic) or unresectable gastric cancer or gastroesophageal junction adenocarcinoma (GEJ) as determined by the investigator;
Past systemic treatment for gastric cancer;
There is a history of malignant tumors in the 5 years before screening (except for gastric cancer), except for malignant tumors with negligible risk of metastasis or death (for example, 5-year OS rate> 90%), such as cervical carcinoma in situ after appropriate treatment , Non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I uterine cancer;
Severe cardiovascular and cerebrovascular events occurred within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage and cerebral infarction (except for lacunar infarcts that are asymptomatic and do not require treatment);
There are other lung diseases that require treatment or are serious, including but not limited to active tuberculosis, interstitial lung disease, etc.;

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 PD-1 and Neoadjuvant Chemotherapydisitamab vedotin：2.5mg/kg, iv,d1,q2w,6cycle PD-1(Sintilimab ):200mg,iv,d1,q2w,6cycle Capecitabine:1000mg/m2,po,bid,d1-14,q3w,4cycle	Drug	disitamab vedotin + PD-1+Capecitabine

Primary outcome

pathologic Complete Response, PCR
Time frame: 3 months-6 months
After completion of neoadjuvant systemic therapy (NAST), hematoxylin and eosin (H\&E) assessments were performed on the completely resected gastric cancer or gastroesophageal junction adenocarcinoma sample and all sampled regional lymph nodes. No evidence of residual active tumor cells was found (currently YpT0N0 in the 8th edition of the AJCC staging system)

5 secondary outcomes

Major pathologic response, MPR
Time frame: 3 months-6 months
R0 resection rate
Time frame: 3 months -6 months
Objective response rate, ORR
Time frame: 3 months-6 months
Relapse-free survival time , RFS
Time frame: 1-5 years
Overall survival , OS
Time frame: 1-5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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. This study is not recruiting at the moment.

liying zhao, PhD contact

hao liu, PhD contact

guoxin li, PhD principal investigator

Southern Hospital of Southern Medical University

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Disitamab Vedotin Combined With PD-1 and Neoadjuvant Chemotherapy in people with Gastric Cancer, run by Guoxin Li.

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 8 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: status not confirmed, as of the sponsor's last update on 9 Nov 2021. 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 liying zhao, PhD (13430396746, gzliguoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathologic Complete Response, PCR (time frame: 3 months-6 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 NCT05113459.

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 Nov 2021.