Health TrialsbyHealthPanel

SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

ConditionSecond-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC/GEJC patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years old (including boundary values)

Volunteer to participate in this clinical study and sign informed consent;

ECOG score 0-1;

Expected survival ≥3 months;

Disqualifiers

Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study

HER2 posotive (IHC 3+ or IHC 2+/ISH +);

Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;

Individuals with Leptomeningeal metastasis or Active brain metastases;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A1904

    Drug

    SHR-A1904

  • Paclitaxel, Docetaxel, Irinotecan

    Drug

    Paclitaxel, Docetaxel, Irinotecan

Treatment groups

524 Participants
are divided into 2 treatment groups
Group A: Treatment group A: SHR-A1904Experimental treatment 1 intervention
Group B: Treatment group B: Paclitaxel, Docetaxel, Irinotecan.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

Measure description: Defined as time from randomization until the date of death due to any cause

Time frame
Until death, assessed up to approximately 2 years

Secondary outcomes

1

Progression-free survival (PFS) by investigator assessment

Measure description: Defined as time from randomization until progression or death as assessed by the investigator

Time frame
Until progression or death, assessed up to approximately 1 year
2

Objective response rate (ORR) by investigator assessment

Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator

Time frame
Until progression, assessed up to approximately 1 year
3

Duration of response (DOR) by investigator assessment

Measure description: Defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death assessed by the investigator

Time frame
Until progression or death, assessed up to approximately 1 year
4

Disease control rate (DCR) by investigator assessment

Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) assessed by the investigator

Time frame
Until progression, assessed up to approximately 1 year

Other outcomes

Sponsors and contacts

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

Shanghai Hengrui Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now