^
Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | Gastric Cancer |
| Drug: | Irene (pyrotinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) + AiRuiKang (dalpiciclib) (CDK4 inhibitor, CDK6 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study to Evaluate SHR6390 Combined With Pyrotinib in Patients With HER2 Positive Gastric Cancer
Excerpt:
...- Patients definitely diagnosed by pathology as Her2 positive stage III/IV gastric cancer...
Trial ID:
Source:
Title:
Pyrotinib combined with SHR6390 in the treatment of refractory advanced HER2-positive gastric cancer or solid tumors: Safety and efficacy results from a phase Id trial.
Published date:
01/17/2023
Excerpt:
A phase Id trial was conducted to evaluate the safety of pyrotinib combined with SHR6390 in refractory advanced HER2 positive gastric cancer or solid tumors....The overall ORR was 40.9%, with median PFS and OS of 3.88 (95%CI 3.46, 4.30) and 11.14 (95%CI 4.50, 17.78) months, respectively. Among GC patients (n=18), 16 pts finished efficacy assessment, 8 pts achieved PR (5 pts having prior anti-HER2 regimens) and 7 achieved SD, with ORR and DCR of 50.0% and 93.8%, respectively....Pyrotinib combined with SHR6390 showed acceptable safety profile and encouraging efficacy.
DOI:
10.1200/JCO.2023.41.3_suppl.368
Trial ID:
Source:
Title:
Pyrotinib combined with SHR6390 in the treatment of refractory advanced HER2 positive gastric cancer or solid tumors: Safety and efficacy results from a phase Id trial
Published date:
05/19/2021
Excerpt:
pyrotinib combined with SHR6390 in the treatment of refractory advanced HER2 positive gastric cancer or solid tumors (NCT03480256)...19 pts (14 gastric cancer, 3 colorectal cancer, 2 other solid tumors) were enrolled...overall response rate was 38.9%, with 7 PR (A: n = 3; E: n = 2; F: n = 2) and 7 SD. The median PFS was 3.83 months, with 2 pts received treatment over 12 months (A: n = 1; F: n = 1). Pyrotinib combined with SHR6390 had shown acceptable safety profile and encouraging efficacy in refractory advanced HER2 positive solid tumors.
DOI:
10.1200/JCO.2021.39.15_suppl.e16009
Trial ID:
Source:
Title:
Pyrotinib combined with CDK4/6 inhibitor in HER2-positive metastatic gastric cancer: A promising strategy from AVATAR mouse to patients
Published date:
08/13/2020
Excerpt:
...a prospective phase I, single‐arm, open‐label, dose‐escalating study (NCT03480256) was designed to evaluate the safety and efficacy of pyrotinib combined with SHR6390 in patients with HER2‐positive AGC after failure of systematic treatments….After two cycles of pyrotinib plus SHR6390 treatment, multiple target lesions in patient 1, 2, and 3 significantly reduced in size accompanied by decreased tumor biomarkers with the clinical response of PR...
DOI:
10.1002/ctm2.148
Trial ID:
