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First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

ConditionsHER2-positive Gastric CancerMetastatic Gastric CancerUnresectable Gastric Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University

About this trial

This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged18-80 years, gender is not limited;

Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;

HER2-Positive (IHC3+or IHC2+/FISH+) ;

Has at least 1 measurable lesion as determined by RECIST 1.1;

Disqualifiers

Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;

Cardiovascular and cerebrovascular events that are not well controlled;

Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks.

Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Disitamab Vedotin

    Drug

    2.5 mg/kg IV every 3 weeks

  • Sintilimab

    Drug

    200 mg IV every 3 weeks

  • S-1

    Drug

    40-60 mg BID for 14 days, every 3 weeks

  • Trastuzumab

    Drug

    First load dose is 8.0mg/kg , then 6.0 mg/kg IV every 3 weeks

  • Oxaliplatin

    Drug

    130 mg/m2 Q3W

  • Capecitabine

    Drug

    1000 mg/m² Q3W

  • 5-FU

    Drug

    800 mg/m²

  • Cisplatin

    Drug

    80 mg/m²

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Disitamab Vedotin+Sintilimab+S-1Experimental treatment 3 interventions
Group B: Trastuzumab+Chemotherapy（XELOX/FP/XP) ± SintilimabActive comparator 6 interventions

Trial outcomes

Primary outcomes

1

Objective remission rate (ORR)

The proportion of subjects with complete response (CR) and partial response (PR) in total subjects

Time frame
6 months after the last subject participating in

Secondary outcomes

1

Progression-free survival (PFS)

Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.

Time frame
12 months after the last subject participating in
2

Overall survival (OS)

Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.

Time frame
12 months after the last subject participating in
3

Duration of relief (DOR)

DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

Time frame
12 months after the last subject participating in
4

Disease control rate (DCR)

The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects

Time frame
6 months after the last subject participating in

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Hospital of Shandong University

Lead sponsor

Source ClinicalTrials.gov
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