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Gastric CancerPhase 2NCT06227325

Disitamab Vedotin Combined With Sintilimab and XELOX Perioperative Treatment for Resectable Gastric Caner With HER2 Overexpression

A Phase 2 study testing RC48 combined with Sintilimab and XELOX in people with Gastric Cancer, run by Henan Cancer Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of RC48 combined withSintilimab and chemotherapy in perioperative therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
RC48 combined with Sintilimab and XELOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
1 Feb 2024to 31 Dec 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects volunteered to join the study, could complete the signing of the informed consent form, and had good compliance;
  • Aged at least 18-75 years, male or female;
  • Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology is diagnosed as cT3-4aN1-3M0 according to AJCC version 8, and cTNM is diagnosed as cT3-4aN1-3M0 according to endoscopic ultrasonography or enhanced CT/MRI scanning (combined with ultrasonic gastroscopy and diagnostic laparoscopic exploration if necessary), and the researcher evaluates that the lesion is resectable;
  • Have not received systematic treatment for current diseases in the past, including surgical treatment, anti-tumor radiochemotherapy/immunotherapy, etc;
  • Patients who agree to receive radical surgical treatment and have no surgical contraindication as judged by the surgeon.
  • IHC(immuno-histochemistry) results confirmed HER2 expression (defined as IHC 2+and 3+);
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  • ECOG (Eastern Cooperative Oncology Group) score 0-1;
  • Expected life ≥ 6 months;
  • The main organs function well and meet the standards:
  • The fertile subjects must use appropriate methods of contraception during the study period and within 120 days after the end of the study. The serum pregnancy test was negative within 7 days before the study was included, and they must be non lactating subjects.

Who cannot join

  • Malignant diseases other than gastric cancer diagnosed within 5 years prior to initial administration;
  • Known endoscopic signs of active bleeding;
  • The subject is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing;
  • Previous treatment with anti-HER2, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulus or synergistic inhibition of T cell receptors;
  • Received systemic systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration;
  • An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;
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  • Was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration;
  • Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
  • Known allergy to the drugs used in this study;
  • Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);
  • Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
  • Untreated active hepatitis B (defined as HBsAg positive and HBV(hepatitis B virus)-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center);
  • Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
  • Received live vaccine within 30 days prior to the first dose (cycle 1, day 1);
  • Pregnant or lactating women;
  • The presence of any serious or uncontrolled systemic disease;
  • Evidence of medical history or disease that might interfere with the test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The Investigator considers other potential risks unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country.

Ying Liu contact

+86-13783604602

yaya7207@126.com

China1 site

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Ying Liu, MD, +86-13783604602, yaya7207@126.com

Other trials in China

About this study

Official title: Prospective, Single Center, Phase II Study of Disitamab Vedotin（RC48) Combined With Sintilimab Plus XELOX for Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression

The aim of this study is to observe the efficacy, safety, postoperative pathological response rate and survival benefit of RC48 combined withSintilimab and chemotherapy in perioperative therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma.

Conditions
Gastric Cancer
Being tested
RC48 combined with Sintilimab and XELOX
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • RC48 combined with Sintilimab and XELOXDrug

    Also called Disitamab vedotin combined with Sintilimab and XELOX

    RC48: 2.5 mg/kg, iv, d1, repeat every 2 weeks; Sintilimab: 200mg, iv, d1, repeat every 3 weeks; XELOX: Oxaliplatin 130mg/m2, iv, d1；Capecitabine1000 mg po, bid, d1-14, repeat every 3 weeks

Study groups in NCT06227325
Study groupRoleWhat they receive
treatment groupExperimentalNeoadjuvant therapy:RC48 combined with Sintilimab and XELOX repeat every 2 weeks or every 3 weeks for a total of 3 cycles Adjuvant therapy: RC48 combined with Sintilimab and XELOX repeat every 2 weeks or every 3 weeks for a total of 5 cycles
Receives: Drug: RC48 combined with Sintilimab and XELOX

What is being measured

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

  1. pathological complete response (pCR) rate

    The percentage of patients with no residual cells at the primary cancer site and N(-) per histological evaluation.

    Measured: Up to approximately 12 weeks

Secondary outcomes (6)

  1. R0 resection rate

    The percentage of patients who have no residual cancer cells (gross or microscopically) at the resection margins.

    Measured: Up to approximately 12 weeks

  2. Disease free survival (DFS)

    DFS is defined as the time from postoperative baseline imaging evaluation to disease recurrence or death in subjects who are disease-free after surgery.

    Measured: From randomization to the date of recurrence or death (up to approximately 4 years).

  3. Major pathological response (MPR) rate

    Measured: Up to approximately 12 weeks

  4. Clinical downgrading rate

    Measured: Up to approximately 12 weeks

  5. Overall survival (OS)

    OS is defined as the time from the first dose to all-cause death.

    Measured: From the randomization to the date of death (up to approximately 4 years).

  6. Percentage of Participants who experience one or more adverse events (AEs).

    The incidence and grade of adverse events (including SAE) will be determined per NCI-CTCAE 5.0.

    Measured: 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 posted26 Jan 2024
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (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
Not applicable
Intervention model
Single group
Model description
RC48+PD-1+chemotherapy
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06227325
Sponsor's protocol ID
RCVDTYPEC067
Status last verified
Sep 2023
First submitted
11 Jan 2024
Last updated
26 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC48 combined with Sintilimab and XELOX in people with Gastric Cancer, run by Henan Cancer Hospital at 1 site 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 10 inclusion and 17 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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Ying Liu (+86-13783604602, yaya7207@126.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 12 weeks). 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 NCT06227325.

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 26 Jan 2024.

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