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FeasibilityNCT05177666

a Prospective Registration Study for Patients With Advanced Refractory Solid Tumors

An observational study of Feasibility and Effectiveness, run by The University of Hong Kong-Shenzhen Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Feasibility, Effectiveness, Safety
What is being tested?
Targeted therapy
How many people
120 participants
Where
No sites listed yet
Study dates
30 Dec 2021to 30 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Zhiyuan Xu, MD contact

+86-18307555170

xuzy@hku-szh.org

About this study

Official title: Patients With Advanced Refractory Solid Tumors Who Failed Standard Treatments and Matched Individualized Treatment Based on Tumor Molecular Characteristics: a Prospective Registration Study

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.

Read the detailed description
  1. Screen and enroll 120 patients with refractory solid tumors, and sign informed consents;
  2. Extract the clinical data, including gender, age, disease diagnosis, past treatment history and genetic test results, etc.;
  3. Take biopsy samples and perform NGS testing on patients. After discussion by the Molecular Steering Committee (MTB), the recommendations for treatment guidance will be given based on treatment guidelines and clinical experience;
  4. The patient and the clinician jointly select the treatment plan and follow-up until the patient's disease progresses. The follow-up time will be 1 year;
  5. During the follow-up period, clinical treatment and routine examination information of patients will be collected;
  6. If the patient fails to receive molecular targeted therapy or they cannot tolerate the adverse reaction of the drug after adequate treatment, the clinician will evaluate whether a second NGS resistance test is needed or the participant may withdraw from the study.
Being tested
Targeted therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Targeted therapyDrug

    Also called Entratinib, Cabotinib, Aletinib, Enmetrastuzumab

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

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

    Measured: 2021.11-2023.11

  2. 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.

    Measured: 2021.11-2023.11

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    PFS is defined as the time from the first administration to disease progression or death.

    Measured: 2021.11-2023.11

  2. Overall survival (OS)

    OS is defined as the time from the first administration to death from any cause.

    Measured: 2021.11-2023.11

  3. Best overall response (BOR)

    The effectiveness of a patient would be evaluated multiple times, and the best one is defined as the best overall response.

    Measured: 2021.11-2023.11

  4. Adverse events

    The incidence of serious adverse events in each group, which is judged based on CTCAE v5.0 standard.

    Measured: 2021.11-2023.11

  5. Quality of Life Score (QoL)

    The QoL is evaluated by the scale (0PROMIS-29 Profile v2.1) at each visit period for all the enrolled patients.

    Measured: 2021.11-2023.11

  6. Proportion of patients with intervening genomic variants

    The intervening genomic variants are defined by the conclusion after MTB discussion.

    Measured: 2021.11-2023.11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2022
  2. Study start30 Dec 2021 (estimated)
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05177666
Sponsor's protocol ID
V1
Status last verified
Dec 2021
First submitted
24 Nov 2021
Last updated
4 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22397650

  • 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.

    PubMed 25109877

  • 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.

    PubMed 24071851

  • 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.

    PubMed 25326492

  • 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.

    PubMed 20921468

  • 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.

    PubMed 22966018

  • 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.

    PubMed 26873727

  • 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.

    PubMed 26342236

  • 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.

    PubMed 27853199

  • 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.

    PubMed 32853681

Questions about this trial

What is this clinical trial studying?

An observational study of Feasibility and Effectiveness, run by The University of Hong Kong-Shenzhen Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhiyuan Xu, MD (+86-18307555170, xuzy@hku-szh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 2021.11-2023.11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05177666, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.

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