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Gastric Cancer/Gastroesophageal Junction AdenocarcinomaPhase 2NCT06385873

RC48 Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer

A Phase 2 study testing RC48, Adebrelimab and Apatinib in people with Gastric Cancer/Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a prospective, open-label, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab, Apatinib and S-1. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
RC48, Adebrelimab and Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
1 May 2024to 1 May 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. Participants voluntarily join this study, are able to complete the signing of the informed consent form, and have good compliance;
  • 2. Age between 18 to 75 years old (at the time of signing the informed consent form), with no gender restrictions;
  • 3. Gastrointestinal cancer or gastroesophageal junction adenocarcinoma confirmed by histology and/or cytology, diagnosed as locally advanced according to the 8th edition of the AJCC standards, with a cTNM diagnosis of T3-4aN+M0 and T4aNanyM0 based on ultrasound endoscopy or enhanced CT/MRI scan (and diagnostic laparoscopy if necessary), and agree to receive curative surgical treatment, with the investigator assessing the potential for tumor resectability;
  • 4. Have not previously received systemic treatment for the current disease, including anti-tumor chemotherapy/immunotherapy, etc.;
  • 5. HER2 overexpression confirmed by IHC results from endoscopic biopsy tissue (defined as: IHC 2+, 3+);
  • 6. ECOG score of 0-1;
  • 7. Estimated life expectancy of ≥6 months;
  • 8. Good major organ function:

Who cannot join

  • 1. Concurrent malignant disease other than gastric cancer (excluding early-stage tumors that have been radically treated);
  • 2. Tumor lesions with a tendency to bleed (such as active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis or melena within 2 months before signing the informed consent form, or assessed by the investigator as being at risk of significant gastrointestinal hemorrhage, etc.) or having received blood transfusion treatment within 4 weeks before the study medication; 3. Inability to take oral medication;
  • 4. Currently participating in another interventional clinical study treatment, or having received other investigational drugs or used investigational medical devices within 4 weeks before the first administration of the study medication;
  • 5. Has had systemic treatment required within 2 years before the first administration of the study medication;
  • 6. Known allogeneic organ transplantation (except for corneal transplantation);
  • 7. Known allergy to any medication used in this study;
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  • 8. Peripheral neuropathy of grade ≥2;
  • 9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies);
  • 10. Active hepatitis B or C infection;
  • 11. Received live vaccines within 30 days before the first administration (Day 1 of Cycle 1);
  • 12. Pregnant or breastfeeding women;
  • 13. Presence of any severe or uncontrollable systemic disease.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xiaofeng Chen, Ph.D contact

13585172066

chenxiaofengnjmu@163.com

Hao Xu, Ph.D contact

13851530117

66881866@qq.com

About this study

Official title: Disitamab Vedotin Combined With Adebrelimab, Apatinib and S-1 as Neoadjuvant Therapy in Locally Advanced Gastric Cancer With HER2 Overexpression: a Prospective, Phase II Study

This study is a prospective, open-label, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab, Apatinib and S-1. The purpose is to evaluate the effectiveness and safety of the combined coordinated treatment of multi-mechanism drugs for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.

Read the detailed description

The study plans to enroll 32 subjects. After signing the informed consent form and meeting the inclusion and exclusion criteria, patients will receive standard-dose treatment of the RC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3 weeks) before surgery. Apatinib will only be used for 14 days in the last cycle. Imaging studies will be conducted 3-4 weeks after the last dose to assess the efficacy of neoadjuvant therapy and the possibility of radical D2 gastrectomy. The treatment plan after curative surgery for gastric cancer will be determined by the investigators and the patients based on the pathological findings. Patients who benefit clinically after surgery may receive adjuvant therapy with RC48, Adebrelimab, Apatinib and S-1 for 4 cycles (the first treatment is expected to start around 4 weeks after surgery) or follow the standard postoperative adjuvant regimen recommended by the guidelines.

Being tested
RC48, Adebrelimab, Apatinib, S-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.

  • RC48Drug

    Also called Disitamab Vedotin

    RC48: 2.5 mg/kg, intravenous infusion, on day 1, every 3 weeks (Q3W);

  • AdebrelimabDrug

    Adebrelimab：1200 mg, intravenous infusion, on day 1, every 3 weeks (Q3W);

  • ApatinibDrug

    Apatinib: 250mg, oral administration, once daily (qd), every 3 weeks (Q3W);

  • S-1Drug

    Also called S-1tegafur, gimeracil and oteracil potassium

    S-1：For patients with a body surface area (BSA) ≤1.5m², use 50mg each time; for patients with BSA >1.5m², use 60mg each time, oral administration, twice daily (bid), on days 1-14, every 3 weeks (Q3W);

Study groups in NCT06385873
Study groupRoleWhat they receive
ExperimentalExperimentalRC48, Adebrelimab, Apatinib and S-1 regimen for 3-4 cycles (every 3 weeks) before surgery.
Receives: Drug: RC48; Drug: Adebrelimab; Drug: Apatinib; Drug: S-1

What is being measured

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

  1. Pathological Complete Response Rate (pCR)

    Defined as the proportion of subjects with no residual viable tumor cells on microscopy and negative lymph nodes out of the total number of subjects;

    Measured: 4 months

Secondary outcomes (4)

  1. Major Pathological Response rate (MPR)

    Defined as the proportion of subjects with ≤10% viable tumor cells in the resected specimen out of the total number of subjects;

    Measured: 4 months

  2. R0 Resection rate

    Complete tumor resection during surgery with negative microscopic margins, meaning no residual tumor;

    Measured: 4 months

  3. Disease-Free Survival (DFS）

    Defined as the time from enrollment to the first radiological evidence of disease recurrence or death (whichever occurs first)

    Measured: 24 months

  4. Overall Survival (OS)

    Defined as the time from enrollment to the subject's death from any cause

    Measured: 36 months

Timeline

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

  1. First posted26 Apr 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2028 (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
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06385873
Sponsor's protocol ID
2024-SR-233
Status last verified
May 2024
First submitted
24 Apr 2024
Last updated
13 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ding Y, Qian H, Liu H, Zhang J, Zhang X, Wei J, Chen X, Xu H. DAWN trial: a prospective, multicenter, single-arm phase II study of neoadjuvant disitamab vedotin (RC48) in combination with adebrelimab, apatinib, and S-1 for locally advanced HER2-positive gastric cancer. J Gastrointest Oncol. 2026 Feb 28;17(1):31. doi: 10.21037/jgo-2025-aw-959. Epub 2026 Feb 12.

    PubMed 41816563

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC48, Adebrelimab and Apatinib in people with Gastric Cancer/Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University.

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 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: opening soon, as of the sponsor's last update on 13 May 2024. 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?

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 Xiaofeng Chen, Ph.D (13585172066, chenxiaofengnjmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response Rate (pCR) (time frame: 4 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 NCT06385873, which also lists 1 linked publication.

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 13 May 2024.

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