Clinical trial · Interventional
Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy
A Phase 1B/2 Study of Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy (TREAZURE)
NCT05640830CI-TRIAL-00082990TREAZURErecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, open-label, prospective, phase 2 study of trastuzumab, bevacizumab, and paclitaxel as second-line treatment for patients with HER2-positive advanced gastric cancer who had progressed on first-line chemotherapy including trastuzumab or anti-HER2 agents.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Advanced Gastric Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trastuzumab, bevacizumab with paclitaxel (triple combination) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TREAZURE
- description
- This is a single arm study. Trastuzumab has been administered at 6 mg/kg every 3 weeks after initial loading of 8 mg/kg during the first anticancer treatment, so in the second anticancer treatment, 4 mg/kg is administered every 2 weeks to maintain the same concentration. Bevacizumab is administered at 5 mg/kg at 2-weekly intervals used in metastatic colorectal cancer. Paclitaxel is administered on a standard schedule of 80 mg/m2 for 3 consecutive weeks followed by a 1-week break as an existing weekly regimen, and when side effects occur, the weekly dose is reduced by 25% to 60 mg/m2 for 3 weeks or administered every 2 weeks. Administer 80 mg/m2. Administration of this drug is set as one cycle of 4 weeks.
- interventionNames
- Drug: trastuzumab, bevacizumab with paclitaxel (triple combination)
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- up to 36 months
- description
- Defined as the time from the start of treatment to the date of documented disease progression (according to RECIST 1.1) or death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. HER2-positive advanced gastric cancer * Defined as IHC 2+, which is IHC 3+ or SISH + (or FISH) evaluated by laboratory tests. (SISH positivity is defined as the ratio of the HER2 gene copy number to the CEP17 signal ≥ 2.0) * or significant overexpression of HER2 protein on target proteomic analysis (multiple reaction monitoring) 2. Patients who have progressed in response to one systemic anticancer therapy for advanced gastric cancer 3. Patients who are willing and able to write a written consent form for this trial. 4. Patients aged 19 years or older at the time of signing the subject consent form. 5. Patients with measurable or evaluable lesions according to RECIST 1.1. 6. ECOG activity status 0, 1 or 2 7. as patients with adequate organ function * Absolute neutrophil (ANC) ≥1.0 x 109/L, platelet ≥100 x 109/L, hemoglobin ≥9 g/dL, serum creatinine ≤1.5 x ULN, total bilirubin ≤3.0 mg on laboratory tests within 2 weeks before starting treatment /dL, AST/ALT ≤5 x ULN * Echocardiogram EF ≥55% or MUGA scan ≥50% Exclusion Criteria: 1. Patients who have received chemotherapy, radiation therapy, immunotherapy or targeted therapy for gastric cancer within the past 2 weeks. 2. Patients who have experienced Grade 3-4 gastrointestinal bleeding within 3 months 3. Patients who have experienced an arteriovascular embolism event, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular disorder, or unstable angina within 6 months 4. Ongoing or active infection, symptomatic congestive heart failure, unstable angina, symptomatic or poorly controlled cardiac arrhythmias, uncontrolled thrombotic or hemorrhagic disorders, or any other serious medical disorder not controlled in the investigator's judgment patient with 5. Patients with a history of gastrointestinal perforation or fistula within 6 months. 6. Concomitant diagnosis of cancer in another site or history of active malignant tumor within the past 3 years * Excluding fully cured basal cell carcinoma and thyroid cancer, in situ cervical cancer
References
Publications (11)
- BACKGROUNDYonemura Y, Ninomiya I, Yamaguchi A, Fushida S, Kimura H, Ohoyama S, Miyazaki I, Endou Y, Tanaka M, Sasaki T. Evaluation of immunoreactivity for erbB-2 protein as a marker of poor short term prognosis in gastric cancer. Cancer Res. 1991 Feb 1;51(3):1034-8. PMID 1670998
- BACKGROUNDBang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. PMID 20728210
- BACKGROUNDGuideline Committee of the Korean Gastric Cancer Association (KGCA), Development Working Group & Review Panel. Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach. J Gastric Cancer. 2019 Mar;19(1):1-48. doi: 10.5230/jgc.2019.19.e8. Epub 2019 Mar 19. No abstract available. PMID 30944757
- BACKGROUNDShitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Yamaguchi K; DESTINY-Gastric01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020 Jun 18;382(25):2419-2430. doi: 10.1056/NEJMoa2004413. Epub 2020 May 29. PMID 32469182
- BACKGROUNDdu Manoir JM, Francia G, Man S, Mossoba M, Medin JA, Viloria-Petit A, Hicklin DJ, Emmenegger U, Kerbel RS. Strategies for delaying or treating in vivo acquired resistance to trastuzumab in human breast cancer xenografts. Clin Cancer Res. 2006 Feb 1;12(3 Pt 1):904-16. doi: 10.1158/1078-0432.CCR-05-1109. PMID 16467105
- BACKGROUNDSingh R, Kim WJ, Kim PH, Hong HJ. Combined blockade of HER2 and VEGF exerts greater growth inhibition of HER2-overexpressing gastric cancer xenografts than individual blockade. Exp Mol Med. 2013 Nov 1;45(11):e52. doi: 10.1038/emm.2013.111.