A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression (NCT04714190) | Clinical Trial Compass
UnknownPhase 3
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression
China351 participantsStarted 2021-03-24
Plain-language summary
This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression locally advanced or metastatic gastric cancer.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntary agreement to provide written informed consent.
* Male or female, Age ≥ 18 years.
* Predicted survival ≥ 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically.Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
* Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
* Adequate organ function.
* All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma
* Have had progression or intolerance following receipt of at least two systemic chemotherapy for advanced or metastatic disease.
* The HER2 IHC test result is IHC 2+ or IHC 3+, the subject's previous test results (confirmed by the investigator) or the research center's test results are acceptable; the subject can provide the Specimen of primary or metastatic tumor for HER2 review/judgment.
* HER2 classic positive (definition: IHC3+ or IHC2+FISH+) and patients who have previously failed standard treatment
* According to the RECIST 1.1 standard, there is at least one measurable lesion.
Exclusion Criteria:
* Known hypersensitivity to …