Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study

NCT05440357 | Recruiting DMC

• 1 other identifier: No.[2021]784
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 8

Brief Summary

This is a prospective, multicenter, observational real-world study to explore the second-line Pharmacotherapy patterns and clinical outcomes in GIST patients who progressed on or were intolerant to first-line anticancer treatment.

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate

  The primary objective is to demonstrate the proportion of patients with progression-free survival (PFS) determined by radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST following the second-line treatment.

  1 year

Secondary Outcomes (7)

• Progression-free survival

  2 years

• overall survival (OS)

  2 years

• objective response rate (ORR)

  2 years

• Time to objective response

  1 year

• R0/R1 resection rate

  2 years

Other Outcomes (1)

• To explore the association of cilinical outcomes with treatment pattern

  2 years

Eligibility Criteria

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

Study Population

Approximately 100 patients with metastatic or unresectable advanced gastrointestinal stromal tumors from tier-3 hospitals who meet the criteria will be enrolled in the study.

You may qualify if:

• Patients who are aged ≥ 18 years.
• Patients who have histologically confirmed metastatic or unresectable GIST.
• Patients who received imatinib at a fixed dose or 1 other TKI as prior treatment regimens. Patients who experienced intolerance to prior therapies must have objective disease progression before enrollment.
• Patients must have at least a measurable lesion according to mRECIST Version 1.1.
• According to the current GIST national guidelines, patients who receive second-line treatments, including but not limited to sunitinib, imatinib dose escalation, ripretinib, dasatinib, and other drug treatments.
• Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at screening.

You may not qualify if:

• Patients who previously received two or more TKIs as prior treatment regimens.
• Patients with a life expectancy of fewer than three months.
• Patients who are pregnant and lactating.
• Patients with an estimated poor adherence or inability to complete follow-up.
• Patients who are not appropriate to enroll due to the investigator's consideration.

Sponsors & Collaborators

• Xinhua Zhang, MD: lead
• Guangdong Provincial People's Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Peking University Shenzhen Hospital: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator
• Hainan Cancer Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Yunnan Cancer Hospital: collaborator
• Chongqing University Cancer Hospital: collaborator

Study Sites (8)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510014, China

RECRUITING

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

The first affiliated hospital,Sun yat-sen university

Guangzhou, Guangdong, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

Hainan Cancer Hospital

Haikou, Hannan, China

RECRUITING

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Related Publications (5)

• Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38. doi: 10.1016/S0140-6736(06)69446-4.

  PMID: 17046465 BACKGROUND

• Li J, Gao J, Hong J, Shen L. Efficacy and safety of sunitinib in Chinese patients with imatinib-resistant or -intolerant gastrointestinal stromal tumors. Future Oncol. 2012 May;8(5):617-24. doi: 10.2217/fon.12.29.

  PMID: 22646775 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

• Schuetze SM, Bolejack V, Thomas DG, von Mehren M, Patel S, Samuels B, Choy E, D'Amato G, Staddon AP, Ganjoo KN, Chow WA, Rushing DA, Forscher CA, Priebat DA, Loeb DM, Chugh R, Okuno S, Reinke DK, Baker LH. Association of Dasatinib With Progression-Free Survival Among Patients With Advanced Gastrointestinal Stromal Tumors Resistant to Imatinib. JAMA Oncol. 2018 Jun 1;4(6):814-820. doi: 10.1001/jamaoncol.2018.0601.

  PMID: 29710216 BACKGROUND

• Kikuchi H, Hiramatsu Y, Kamiya K, Morita Y, Sakaguchi T, Konno H, Takeuchi H. Surgery for metastatic gastrointestinal stromal tumor: to whom and how to? Transl Gastroenterol Hepatol. 2018 Mar 5;3:14. doi: 10.21037/tgh.2018.02.02. eCollection 2018.

  PMID: 29682621 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

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

• zhang xinhua, PhD

  First affiliated hosptial,Sun Yat-sen university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhang xinhua, PhD

CONTACT

+8620-87332200; zhangxinhua@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: First Affiliated Hospital, Sun Yat-Sen University

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: July 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 26, 2025

Record last verified: 2024-05

Locations

CN (8)