a Prospective Registration Study for Patients With Advanced Refractory Solid Tumors

Safety Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05177666
• Other study ID #: V1
• Status: Not yet recruiting
• Start date: December 30, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: December 2021
• Source: The University of Hong Kong-Shenzhen Hospital
• Contact: Zhiyuan Xu, MD
• Phone: +86-18307555170
• Email: xuzy[@]hku-szh.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Effectiveness
• Feasibility
• Safety
• Targeted Molecular Therapy

Intervention

Drug:
• Targeted therapy
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong-Shenzhen Hospital	Tianjin Happy Life Technology Co., Ltd.

References & Publications (10)

Abrahams E, Eck SL. Molecular medicine: Precision oncology is not an illusion. Nature. 2016 Nov 17;539(7629):357. doi: 10.1038/539357e. — View Citation

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. — View Citation

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-Den — View Citation

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, By — View Citation

Le Tourneau C, Delord JP, Gonçalves A, Gavoille C, Dubot C, Isambert N, Campone M, Trédan O, Massiani MA, Mauborgne C, Armanet S, Servant N, Bièche I, Bernard V, Gentien D, Jezequel P, Attignon V, Boyault S, Vincent-Salomon A, Servois V, Sablin MP, Kamal — View Citation

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, Bièche I, Rouleau E, Jezdic S, Douillard JY, Reis-Filho JS, Dienstmann R, André F. — View Citation

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 — View Citation

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 Cance — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in ECOG score before and after treatment	We compare the ECOG scores of each visit with the baseline, including the number and proportion, and the difference.	2021.11-2023.11
Other	Proportion of targeted therapy guided by second tumor molecular characteristics	After targeted therapy drug resistance, then the proportion of targeted therapy guided by the second tumor molecular characteristics would be calculated during study period.	2021.11-2023.11
Primary	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
Primary	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	Progression-free survival (PFS)	PFS is defined as the time from the first administration to disease progression or death.	2021.11-2023.11
Secondary	Overall survival (OS)	OS is defined as the time from the first administration to death from any cause.	2021.11-2023.11
Secondary	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.	2021.11-2023.11
Secondary	Adverse events	The incidence of serious adverse events in each group, which is judged based on CTCAE v5.0 standard.	2021.11-2023.11
Secondary	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.	2021.11-2023.11
Secondary	Proportion of patients with intervening genomic variants	The intervening genomic variants are defined by the conclusion after MTB discussion.	2021.11-2023.11