A Phase II Clinical Study of Fruquintinib Combined With RC48 in the Treatment of Previously Treat… (NCT05241899) | Clinical Trial Compass
UnknownPhase 2
A Phase II Clinical Study of Fruquintinib Combined With RC48 in the Treatment of Previously Treated HER2-positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Cancer
China56 participantsStarted 2022-05-07
Plain-language summary
Although Pembrolizumab plus trastuzumab and chemotherapy is the standard of care for first-line treatment of HER2-positive advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer,there is no established therapy in the second-line setting.
RC48 showed promising activity with manageable safety in patients with HER2-overexpressing, advanced G/GEJ cancer who have previously received at least two lines of chemotherapy.Fruquintinib in combination with Paclitaxel demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC in ph1b/2 study.
This study is aimed to evaluate the efficacy and safety of Fruquintinib in combination with RC48 in the treatment of previously treated HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged 18-75years (inclusive);
✓. Body weight ≥40 kg;
✓. Physical status score (ECOG score) 0-1;
✓. Expected survival \>12 weeks.;
✓. At least one measurable lesion (according to RECIST1.1);
✓. Histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic HER2 positive G/GEJ cancer;
✓. HER2-positive defined as either immunohistochemistry (IHC) 3+ or IHC 2+ in combination with in-situ hybridization positive (ISH+) or fluorescent in-situ hybridization (FISH), as assessed by central review on primary or metastatic tumor;
✓. Fail in previous first-line standard chemotherapy;
Exclusion criteria
✕. An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization
What they're measuring
1
Progression free survival (PFS)
Timeframe: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year
Trial details
NCT IDNCT05241899
SponsorThe First Affiliated Hospital of Zhengzhou University
. Prior treatment with RC48, Fruquintinib, or apatinib either as single agents or as part of a treatment regimen.
✕. Treatment with any investigational anticancer drug within 21 days of the first study treatment administration
✕. More than one prior line of therapy for advanced G/GEJ cancer;
✕. History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
✕. Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization