Health TrialsbyHealthPanel

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

ConditionsGastric CancerGastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRemeGen Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capecitabine

    Drug

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

  • oxaliplatin

    Drug

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

  • Disitamab Vedotin

    Drug

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

  • Toripalimab

    Drug

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: XELOX (capecitabine + oxaliplatin)Active comparator 2 interventions
Group B: Disitamab Vedotin + ToripalimabExperimental treatment 2 interventions
Group C: Disitamab Vedotin + Toripalimab + XELOXExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

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)

Time frame
Up to approximately 2 years

Secondary outcomes

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).

Time frame
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

Time frame
Up to approximately 2 years
3

Tumor regression grade (TRG) score

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

Time frame
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;

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

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

RemeGen Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now