Evaluate the Efficacy and Safety of Radiotherapy Combined With Ripretinib in the Treatment of Unresectable Advanced GIST

NCT06507683 | Recruiting

• 1 other identifier: 1.0 /2024.05.01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective study is to learn whether there is a synergistic effect when radiotherapy is combined with ripretinib in the treatment of patients with unresectable advanced GIST. It will also learn about the safety of this regimen.The main questions it aim to answer is: Dose radiotherapy combined with ripretinib prolong the time to disease progression for patients with advanced GIST?

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• Time to disease progression of irradiated lesions

  Time from start of radiotherapy to progression of irradiated lesions

  Approximately 12 months since the first subject enrolled

Secondary Outcomes (3)

• Time to disease progression of any lesions

  Approximately 12 months since the first subject enrolled

• Overall survival (OS)

  Approximately 12 months since the first subject enrolled

• Objective Response Rate(ORR) of irradiated lesions

  Approximately 12 months since the first subject enrolled

Study Arms (1)

Radiotherapy combined with ripretinib group

EXPERIMENTAL

Radiotherapy (50-70Gy/25-30f)+ ripretinib(150mg QD)

Radiation: simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib

Interventions

simultaneous integrated boost intensity-modulated radiation therapy combined with ripretinib RADIATION

A cumulative radiation dose of 50 to 70 Gy is administered in 25-30 fractions, 5 fractions per week, to the target lesion(s). ripretinib: oral 150mg QD

Radiotherapy combined with ripretinib group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and signed informed consent;
• age: 18 to 75 years, Male or female
• Patients with histologically confirmed GIST and Imaging evaluated as unresectable recurrent and metastatic disease or locally advanced.
• ECOG Performance Score: 0-2
• Subjects who have progressed or documented intolerance after previous first-line, second-line, and third-line treatments.
• At least one measurable lesion in the abdominal or pelvic cavity that has progressed after frontline treatment
• Adequate organ function and bone marrow reserve

You may not qualify if:

• estimated life-expectancy less than 3 months.
• Patients who have received previous radiotherapy to the proposed radiotherapy site, or the tumor has significant mobility, poor tolerance of radiotherapy in adjacent organs, and who are considered unsuitable for radiotherapy after MDT discussion
• Any other clinically significant comorbidities, which in the judgment of the investigator, could compromise compliance with the protocol, interfere with interpretation of the study results, or predispose the patient to safety risks.
• If female, the patient is pregnant or lactating, or plans to become pregnant during the study treatment period

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (7)

• Hayashi Y, Nguyen VTT. A narrative review of imatinib-resistant gastrointestinal stromal tumors. Gastrointest Stromal Tumor. 2021 Oct;4:6. doi: 10.21037/gist-21-10. Epub 2021 Oct 30.

  PMID: 35814621 BACKGROUND

• Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, Schoffski P, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Meade J, Shi K, Ruiz-Soto R, George S, von Mehren M. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jul;21(7):923-934. doi: 10.1016/S1470-2045(20)30168-6. Epub 2020 Jun 5.

  PMID: 32511981 BACKGROUND

• Joensuu H, Eriksson M, Collan J, Balk MH, Leyvraz S, Montemurro M. Radiotherapy for GIST progressing during or after tyrosine kinase inhibitor therapy: A prospective study. Radiother Oncol. 2015 Aug;116(2):233-8. doi: 10.1016/j.radonc.2015.07.025. Epub 2015 Jul 27.

  PMID: 26228971 BACKGROUND

• Gatto L, Nannini M, Saponara M, Di Scioscio V, Beltramo G, Frezza GP, Ercolani G, Pinna AD, Astolfi A, Urbini M, Brandi G, Biasco G, Pantaleo MA. Radiotherapy in the management of gist: state of the art and new potential scenarios. Clin Sarcoma Res. 2017 Jan 10;7:1. doi: 10.1186/s13569-016-0065-z. eCollection 2017.

  PMID: 28078078 BACKGROUND

• Li L, Yi X, Cui H, Zhao X, Dang J, Jiang Q, Li Y. Simultaneous Integrated Boost Intensity-Modulated Radiotherapy for Locally Advanced Drug-Resistant Gastrointestinal Stromal Tumors: A Feasibility Study. Front Oncol. 2020 Nov 23;10:545892. doi: 10.3389/fonc.2020.545892. eCollection 2020.

  PMID: 33330024 BACKGROUND

• Cui H, Li Y, Huang W, Lu W, Yi X. Escalation of radiotherapy dose in large locally advanced drug-resistant gastrointestinal stromal tumors by multi-shell simultaneous integrated boost intensity-modulated technique: a feasibility study. Radiat Oncol. 2022 Dec 28;17(1):216. doi: 10.1186/s13014-022-02179-z.

  PMID: 36578008 BACKGROUND

• Boruban C, Sencan O, Akmansu M, Atik ET, Ozbek S. Metastatic gastrointestinal stromal tumor with long-term response after treatment with concomitant radiotherapy and imatinib mesylate. Anticancer Drugs. 2007 Sep;18(8):969-72. doi: 10.1097/CAD.0b013e3280e94982.

  PMID: 17667604 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

ripretinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Jun Zhang

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhang, MD

CONTACT

+86 136 1766 6067; zjun2323@sina.cn

Longhao Li, MD

CONTACT

+86 183 7580 7001; llh@hospital.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: May 28, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)