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Gastric CancerPhase 2NCT06155383

Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.

A Phase 2 study testing Capecitabine, oxaliplatin and Disitamab Vedotin in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by RemeGen Co., Ltd. at 11 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
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Capecitabine, oxaliplatin and Disitamab Vedotin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
11 sitesChina
Study dates
27 Nov 2023to 31 Dec 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate and sign the informed consent form;
  • Male or female, ≥18 years;
  • Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology;
  • Clinical stage cT3-4aN+, no distant metastasis (M0);
  • According to the baseline imaging and medical history data evaluated by the Investigators, radical surgery for gastric cancer and R0 resection is expected; Subjects had not previously received any antitumor therapy for gastric or gastroesophageal junction adenocarcinoma;
  • HER2- expression: IHC 1+, 2+, 3+;
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  • ECOG performance status score of 0 or 1;
  • Cardiac function: left ventricular ejection fraction ≥50%;
  • The following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial center):
  • 9.1Bone marrow function:
  • absolute neutrophil count (ANC) ≥1.5×109/L (no treatment with granulocyte colony-stimulating factor within 1 week prior to examination);
  • Platelets ≥100×109/L (platelets should not be transfused within 1 week before the examination, and recombinant human thrombopoietin therapy should not be used within 2 weeks)
  • hemoglobin ≥9g/dL (blood transfusion and erythropoietin treatment are not allowed within 2 weeks prior to the examination);
  • 9.2Liver function:
  • Serum total bilirubin ≤1.5 times the upper limit of normal (ULN);
  • alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤2.5 × ULN;
  • 9.3 Kidney function:
  • a.Blood creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL/min according to Cockcroft-Gault formula method; Female: CrCl= (140-age) × weight (kg) × 0.85 72 × serum creatinine (mg/dL) Male: CrCl= (140-age) × weight (kg) × 1.00 72 × serum creatinine (mg/dL)
  • 9.4 Coagulation function:
  • prothrombin time (PT) ≤1.5×ULN;
  • thrombin time (TT) ≤ 1.5×ULN;
  • activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
  • Female subjects should be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable method of contraception (e.g., intrauterine device, contraceptives, or condoms) for 7 days before the first dose and for 6 months after the end of the study treatment period, and not breastfeed. Blood pregnancy tests must be negative within 7 days prior to study enrollment. Male subjects should agree to use at least one medically approved contraceptive method (e.g., condoms, abstinence, etc.) for 7 days prior to initial dosing and up to 6 months after the end of the study treatment period;
  • Able to understand trial requirements, willing and able to follow trial and follow-up procedures.

Who cannot join

  • Received any anti-tumor therapy for gastric or gastroesophageal junction adenocarcinoma before study dosing, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and other anti-tumor drug therapy (including Chinese medicine treatment with anti-tumor ingredients specified in the instructions within 2 weeks before screening);
  • The investigators considered perioperative period treatment of patients requiring radiotherapy for target lesions；
  • Major surgery was performed within 4 weeks before the start of study dosing and did not fully recover;
  • Patients with active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening;
  • Gastrointestinal perforation/fistula 6 months before screening;
  • Upper digestive tract obstruction that cannot guarantee drug absorption, functional abnormalities or malabsorption syndrome, which can affect the absorption of capecitabine ;
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  • Peripheral polyneuropathy ≥ NCI Ⅱ grade；
  • Serum virology examination (based on the normal value of the research center):
  • Positive HBsAg test with positive HBV DNA copy number;
  • Positive HCVAb test with positive HCV RNA PCR test.
  • Positive HIVAb test.
  • Have received live vaccine within 4 weeks prior to screening or plan to receive any vaccine during the study period (except for the novel coronavirus vaccine);
  • Heart failure rated 3 or higher by the New York College of Cardiology (NYHA);
  • Cardiac chest pain, defined as moderate pain that restricts daily activities, occurred within 28 days prior to screening. There were serious arteriovenous thrombosis events or cardiovascular and cerebrovascular accidents within six months before dosing, such as deep vein thrombosis (except asymptomatic and untreated intermuscular venous thrombosis), pulmonary embolism, cerebral infarction, cerebral hemorrhage, and myocardial infarction (except asymptomatic lacunar infarction that did not require clinical intervention);
  • There is an active or advanced infection that requires systematic treatment (experimental medication may be initiated 2 weeks after the end of anti-infective therapy), such as active tuberculosis;
  • There are systemic diseases that have not been stably controlled which are determined by investigators, including diabetes, hypertension, cirrhosis, etc.;
  • A history of lung disease that requires treatment and has the potential to interfere with surgery, including but not limited to interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, and acute lung disease;
  • Active autoimmune diseases requiring systemic therapy (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs) within 2 years prior to dose administration, and replacement therapies (e.g., thyroxine, insulin, or physiological replacement of glucocorticoids due to renal or pituitary deficiency) are allowed, and a history of refractory autoimmune disease. Systemic use of steroids within 14 days prior to screening (dose > 10 mg/day prednisone or equivalent dose of other glucocorticoids) or other systemic immunosuppressive therapy;
  • Other malignancies within 5 years prior to screening, other than those that have been cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery);
  • Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
  • Allergies to any of the drugs in this study;
  • Known deficiency of dipyrimidine dehydrogenase (DPD);
  • Receiving immunotherapy (including but not limited to interleukin, interferon, thymus hormone) or other investigational drugs within 28 days prior to screening;
  • Pregnant or lactating women;
  • Any other disease, metabolic disorder, or abnormal findings upon physical examination or laboratory examination that makes the subject unsuitable for receiving the investigational drug, affects the interpretation of study outcomes, or poses risks to patient safety, as determined by the investigator;
  • Subject is assessed to be unable or unwilling to comply with the requirements of the protocol.

Trial locations and contacts

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

Jianmin Fang, Ph.D contact

+8610-58075763

Jianminfang@hotmail.com

11 sites in 1 country

China11 sites, 11 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100042

    Ziyu Li, Ph.D

    Recruiting

  • Sichuan Cancer Hospital & Institute

    Chengdu, Sichuan

    Ping Zhao, M.D

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Luchuan Chen, M.D

    Not yet recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    Yong Li, M.D

    Not yet recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong

    Guoxin Li, M.D

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Yanqiao Zhang, M.D

    Not yet recruiting

  • Shandong Cancer Hospital & Institute

    Jinan, Shangdong

    Changzheng Li, M.D

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Fujian

    Wenliang Li, M.D

    Not yet recruiting

  • Gansu Wuwei Tumour Hospital

    Wuwei, Gansu

    Peng Niu, M.D

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Jun You, M.D

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Jing Zhuang, M.D

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase II Study of Perioperative Disitamab Vedotin Plus Toripalimab and XELOX Versus Disitamab Vedotin Plus Toripalimab Versus XELOX in Subjects With HER2-expressing Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Read the detailed description

This is an open-label, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing (immunohistochemical 1+, 2+, 3+) resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Being tested
Capecitabine, oxaliplatin, Disitamab Vedotin, Toripalimab
Keywords
HER2-expressing, gastric cancer, gastroesophageal junction adenocarcinoma
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • CapecitabineDrug

    1000 mg/m2, Bid orally, D1-14, every 3 weeks

  • oxaliplatinDrug

    130 mg/m2, intravenous infusion, D1, every 3 weeks

  • Disitamab VedotinDrug

    Also called RC48

    2.5 mg/kg, intravenous infusion, D1, every 2 weeks

  • ToripalimabDrug

    Also called JS001

    3.0 mg/kg, intravenous infusion, D1, every 2 weeks

Study groups in NCT06155383
Study groupRoleWhat they receive
XELOX (capecitabine + oxaliplatin)Active comparatorcapecitabine with oxaliplatin arm
Receives: Drug: Capecitabine; Drug: oxaliplatin
Disitamab Vedotin + ToripalimabExperimentalDisitamab Vedotin with Toripalimab arm
Receives: Drug: Disitamab Vedotin; Drug: Toripalimab
Disitamab Vedotin + Toripalimab + XELOXExperimentalDisitamab Vedotin + Toripalimab + XELOX arm
Receives: Drug: Capecitabine; Drug: oxaliplatin; Drug: Disitamab Vedotin; Drug: Toripalimab

What is being measured

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

  1. Pathological complete response (pCR) rate

    Proportion of patients with pCR. pCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes (ypT0N0)

    Measured: Up to approximately 2 years

Secondary outcomes (7)

  1. Objective remission rate (ORR)

    The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed).

    Measured: Up to approximately 2 years

  2. R0 resection rate

    Percentage of patients with complete resection of tumor tissue without tumor cell infiltration at surgical margins

    Measured: Up to approximately 2 years

  3. Tumor regression grade (TRG) score

    to evaluate tumor regression grade (based on postoperative pathological reports);

    Measured: Up to approximately 2 years

  4. Major pathological response (MPR)

    the proportion of patients with percentage of residual tumor cells in the tumor bed ≤10% after neoadjuvant therapy;

    Measured: Up to approximately 2 years

  5. Event free survival (EFS)

    the time from randomization to the first occurrence of the following events: radiographic disease progression per RECIST 1.1,local or distant recurrence, and death due to any cause;

    Measured: Up to approximately 2 years

  6. Overall survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 2 years

  7. Adverse events

    to evaluate safety including adverse event rate and adverse event grade

    Measured: Time Frame: Up to approximately 2 years

Timeline

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

  1. First posted4 Dec 2023
  2. Study start27 Nov 2023
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06155383
Sponsor's protocol ID
RC48-C022
Status last verified
Nov 2023
First submitted
23 Nov 2023
Last updated
14 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine, oxaliplatin and Disitamab Vedotin in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by RemeGen Co., Ltd. at 11 sites in China.

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 24 inclusion and 26 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 Jianmin Fang, Ph.D (+8610-58075763, Jianminfang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate (time frame: Up to approximately 2 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 NCT06155383.

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 14 Dec 2023.

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