a Prospective Registration Study for Patients With Advanced Refractory Solid Tumors

NCT05177666 | Unknown DMC

• 1 other identifier: V1
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective registration study for patients with advanced refractory solid tumors. Patients who meet the eligibility criteria will be included to participate in the study, and baseline information to be collected after signed informed consent. Patients will choose for themselves whether to carry out targeted therapy or other appropriate treatment methods. And we plan to follow up for at least 12 months or until disease progression or death.

Conditions

Feasibility; Effectiveness; Safety; Targeted Molecular Therapy

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR)

  ORR is judged based on RECIST 1.1 criteria for all treatment groups at each visit period.

  2021.11-2023.11

• Proportion of targeted therapy guided by tumor molecular characteristics

  The proportion of all enrolled patients receiving targeted therapy guided by tumor molecular characteristics during the study period, would be calculated, which defined as having received one or more the treatments based on tumor molecular characteristics.

  2021.11-2023.11

Secondary Outcomes (6)

• Progression-free survival (PFS)

  2021.11-2023.11

• Overall survival (OS)

  2021.11-2023.11

• Best overall response (BOR)

  2021.11-2023.11

• Adverse events

  2021.11-2023.11

• Quality of Life Score (QoL)

  2021.11-2023.11

Other Outcomes (2)

• Changes in ECOG score before and after treatment

  2021.11-2023.11

• Proportion of targeted therapy guided by second tumor molecular characteristics

  2021.11-2023.11

Interventions

Targeted therapy DRUG

Based on next-generation sequencing (NGS) detection, after discussion by the Molecular Steering Committee (MTB), intervention guidance suggestions are given based on domestic and foreign guidelines and clinical experience, and finally the patient and clinician jointly choose the treatment plan.

Also known as: Entratinib, Cabotinib, Aletinib, Enmetrastuzumab, Trastuzumab, Pertuzumab, Vemurafenib, Atilizumab, Bevacizumab, Erlotizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From November 2021 to November 2022, the patients with refractory tumors who underwet the standard treatment standard treatment, went to the Shenzhen Hospital of the University of Hong Kong and were willing to have genetic testing for individualized targeted therapy. It is planned to enroll 120 patients.

You may qualify if:

• Recurrent or metastatic malignant solid tumor confirmed by histology or cytology
• Disease progression or intolerance after receiving standard treatment
• With evaluable lesions (RECIST 1.1 standard)
• Tumor tissue pieces with sufficient formalin-fixed paraffin-embedded (FFPE) can be used for genetic testing
• ECOG PS score 0-4 (3-4 points only for patients with tumor burden)
• Sign the informed consent form

You may not qualify if:

• The subject is participating in any other clinical research;
• Researchers believe that serious or uncontrolled medical diseases (ie uncontrolled diabetes, chronic kidney disease, chronic lung disease, or uncontrolled active infections, mental illnesses/social conditions that restrict compliance with research requirements) that will confuse the analysis of research treatment response ；
• Patients during pregnancy or lactation

Sponsors & Collaborators

• The University of Hong Kong-Shenzhen Hospital: lead
• Tianjin Happy Life Technology Co., Ltd.: collaborator

Related Publications (10)

• Gerlinger M, Rowan AJ, Horswell S, Math M, Larkin J, Endesfelder D, Gronroos E, Martinez P, Matthews N, Stewart A, Tarpey P, Varela I, Phillimore B, Begum S, McDonald NQ, Butler A, Jones D, Raine K, Latimer C, Santos CR, Nohadani M, Eklund AC, Spencer-Dene B, Clark G, Pickering L, Stamp G, Gore M, Szallasi Z, Downward J, Futreal PA, Swanton C. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med. 2012 Mar 8;366(10):883-892. doi: 10.1056/NEJMoa1113205.

  PMID: 22397650 RESULT

• Hoadley KA, Yau C, Wolf DM, Cherniack AD, Tamborero D, Ng S, Leiserson MDM, Niu B, McLellan MD, Uzunangelov V, Zhang J, Kandoth C, Akbani R, Shen H, Omberg L, Chu A, Margolin AA, Van't Veer LJ, Lopez-Bigas N, Laird PW, Raphael BJ, Ding L, Robertson AG, Byers LA, Mills GB, Weinstein JN, Van Waes C, Chen Z, Collisson EA; Cancer Genome Atlas Research Network; Benz CC, Perou CM, Stuart JM. Multiplatform analysis of 12 cancer types reveals molecular classification within and across tissues of origin. Cell. 2014 Aug 14;158(4):929-944. doi: 10.1016/j.cell.2014.06.049. Epub 2014 Aug 7.

  PMID: 25109877 RESULT

• Ciriello G, Miller ML, Aksoy BA, Senbabaoglu Y, Schultz N, Sander C. Emerging landscape of oncogenic signatures across human cancers. Nat Genet. 2013 Oct;45(10):1127-33. doi: 10.1038/ng.2762.

  PMID: 24071851 RESULT

• Wheler J, Lee JJ, Kurzrock R. Unique molecular landscapes in cancer: implications for individualized, curated drug combinations. Cancer Res. 2014 Dec 15;74(24):7181-4. doi: 10.1158/0008-5472.CAN-14-2329. Epub 2014 Oct 17.

  PMID: 25326492 RESULT

• Von Hoff DD, Stephenson JJ Jr, Rosen P, Loesch DM, Borad MJ, Anthony S, Jameson G, Brown S, Cantafio N, Richards DA, Fitch TR, Wasserman E, Fernandez C, Green S, Sutherland W, Bittner M, Alarcon A, Mallery D, Penny R. Pilot study using molecular profiling of patients' tumors to find potential targets and select treatments for their refractory cancers. J Clin Oncol. 2010 Nov 20;28(33):4877-83. doi: 10.1200/JCO.2009.26.5983. Epub 2010 Oct 4.

  PMID: 20921468 RESULT

• Tsimberidou AM, Iskander NG, Hong DS, Wheler JJ, Falchook GS, Fu S, Piha-Paul S, Naing A, Janku F, Luthra R, Ye Y, Wen S, Berry D, Kurzrock R. Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative. Clin Cancer Res. 2012 Nov 15;18(22):6373-83. doi: 10.1158/1078-0432.CCR-12-1627. Epub 2012 Sep 10.

  PMID: 22966018 RESULT

• Schwaederle M, Parker BA, Schwab RB, Daniels GA, Piccioni DE, Kesari S, Helsten TL, Bazhenova LA, Romero J, Fanta PT, Lippman SM, Kurzrock R. Precision Oncology: The UC San Diego Moores Cancer Center PREDICT Experience. Mol Cancer Ther. 2016 Apr;15(4):743-52. doi: 10.1158/1535-7163.MCT-15-0795. Epub 2016 Feb 12.

  PMID: 26873727 RESULT

• Le Tourneau C, Delord JP, Goncalves A, Gavoille C, Dubot C, Isambert N, Campone M, Tredan O, Massiani MA, Mauborgne C, Armanet S, Servant N, Bieche I, Bernard V, Gentien D, Jezequel P, Attignon V, Boyault S, Vincent-Salomon A, Servois V, Sablin MP, Kamal M, Paoletti X; SHIVA investigators. Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial. Lancet Oncol. 2015 Oct;16(13):1324-34. doi: 10.1016/S1470-2045(15)00188-6. Epub 2015 Sep 3.

  PMID: 26342236 RESULT

• Abrahams E, Eck SL. Molecular medicine: Precision oncology is not an illusion. Nature. 2016 Nov 17;539(7629):357. doi: 10.1038/539357e. No abstract available.

  PMID: 27853199 RESULT

• Mosele F, Remon J, Mateo J, Westphalen CB, Barlesi F, Lolkema MP, Normanno N, Scarpa A, Robson M, Meric-Bernstam F, Wagle N, Stenzinger A, Bonastre J, Bayle A, Michiels S, Bieche I, Rouleau E, Jezdic S, Douillard JY, Reis-Filho JS, Dienstmann R, Andre F. Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group. Ann Oncol. 2020 Nov;31(11):1491-1505. doi: 10.1016/j.annonc.2020.07.014. Epub 2020 Aug 24.

  PMID: 32853681 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The patient undergoes biopsy sampling for next-generation sequencing (NGS) testing.

MeSH Terms

Interventions

Trastuzumab; pertuzumab; Vemurafenib; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yongmei Li, MD

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

• Weitang Wu

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyuan Xu, MD

CONTACT

+86-18307555170; xuzy@hku-szh.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: January 4, 2022
• Study Start: December 30, 2021
• Primary Completion: December 30, 2023
• Study Completion: March 30, 2024
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share