Biomarker-Integrated Umbrella, Advanced Gastric Cancer

Conditions

Gastric Cancer

Brief summary

In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment. The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

Detailed description

In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

Sun Young Rha, Choong‐kun Lee, Hyo Song Kim, Minkyu Jung, Hyunki Kim et al. (15 authors)

Journal of Clinical Oncology2022-06-015 citations

10.1200/jco.2022.40.16_suppl.4001

Combining gene expression analysis of gastric cancer cell lines and tumor specimens to identify biomarkers for anti-HER therapies-the role of HAS2, SHB and HBEGF.

Ebert K, Haffner I, Zwingenberger G, Keller S, Raimúndez E, Geffers R, Wirtz R, Barbaria E, Hollerieth V, Arnold R, Walch A, Hasenauer J, Maier D, Lordick F, Luber B.

2022-03-098 citations

10.1186/s12885-022-09335-4

Genomic profiling as a response predictor of second-line treatment in advanced gastric cancer patients: Post-hoc analyses of two phase Ib/II trials.

Choong‐kun Lee, Jingmin Che, Woo Sun Kwon, Sejung Park, Hyo Song Kim et al. (8 authors)

Journal of Clinical Oncology2022-01-19

10.1200/jco.2022.40.4_suppl.351

Abstract CT159: Open label, single-arm, multi-center phase Ib/II study to evaluate the safety and efficacy of nivolumab in combination with paclitaxel in Epstein-Barr virus (EBV)-related, or microsatellite instability-high (MSI-H), or programmed cell death ligand 1 (PD-L1) positive advanced gastric cancer (AGC)

Rha Sun Young, Jii Bum Lee, Hyo Song Kim, Minkyu Jung, Choong‐kun Lee et al. (11 authors)

Cancer Research2021-07-012 citations

10.1158/1538-7445.am2021-ct159

Interventions

OTHERbiomarker screening

immunohistochemistry and in situ hybridization

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Biomarker-integrated multi-arm with shared standard of care (SOC) control arm

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer 2. Eastern Cooperative Oncology Group performance status of 0 to 1 3. Male or female; ≥ 19 years of age 4. On or progression after 1st line palliative chemotherapy 5. Subjects with evaluable lesion (using RECIST 1.1 criteria) 6. Subjects who meet the following criteria: * Absolute neutrophil count ≥ 1000 /µL * Platelet count ≥ 75,000/ µL * Serum creatinine \< 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min * aspartate aminotransferase and alanine transaminase 3 x upper limit of normal

Exclusion criteria

* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Design outcomes

Primary

Measure	Time frame	Description
progression free survival	6 weeks	progression free survival

Countries

South Korea

Outcome results

None listed