Ripretinib Used for Resectable Metastatic GIST After Failure of Imatinib Therapy

NCT05132738 | Unknown

• 1 other identifier: Ripretinib for GIST
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the efficacy and safety of preoperative treatment of potentially resectable locally advanced or recurrent metastatic gastrointestinal stromal tumor (GIST) after failure of treatment.

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Stromal Tumors; Ripretinib; Imatinib

Outcome Measures

Primary Outcomes (2)

• No Evidence of Disease Rate (NED Rate)

  The primary study endpoint is to investigate the disease-free status rate of ripretinib for the preoperative treatment of potentially resectable locally advanced or recurrent metastatic GIST (NED Rate defined as patients who achieve R0 resection or complete response or macroscopic complete ablation of all known tumor lesions based on imaging assessment, with known tumor lesions assessed by CT or MRI at baseline and within 14 days after surgery, respectively).

  baseline

• No Evidence of Disease Rate (NED Rate)

  The primary study endpoint is to investigate the disease-free status rate of ripretinib for the preoperative treatment of potentially resectable locally advanced or recurrent metastatic GIST (NED Rate defined as patients who achieve R0 resection or complete response or macroscopic complete ablation of all known tumor lesions based on imaging assessment, with known tumor lesions assessed by CT or MRI at baseline and within 14 days after surgery, respectively).

  within 14 days after surgery

Secondary Outcomes (3)

• R0/R1 resection rate

  1 days after surgery

• Surgery rate

  up to 6 months

• Objective response rate (ORR)

  up to 24 months

Other Outcomes (2)

• Recurrence-free survival (RFS)

  until the date of first documented progression, assessed up to 24 months

• Overall survival (OS)

  until the date of death from any cause, assessed up to 24 months

Study Arms (1)

Ripretinib treatment group

EXPERIMENTAL

Drug: Ripretinib treatment

Interventions

Ripretinib treatment DRUG

Ripretinib: 4-week (28-day) cycle of oral administration of 150 mg q.d. For patients who completed up to 6 consecutive treatment cycles in a the clinical investigator decided whether to perform the operation or not, the specific time and other matters. The above medications can be adjusted according to the adverse reactions of subjects according to the protocol at the investigator's discretion. Subjects will continue treatment until disease progression, intolerable toxicity, withdrawal of informed consent, or discontinuation of treatment as judged by the investigator, and the investigator will decide whether to perform early surgery or subsequent treatment regimen.

Ripretinib treatment 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:

• Patients voluntarily, and signed a written informed consent, good compliance with follow-up;
• years ≤ age \< 75 years, male or female;
• Histopathological examination confirmed the diagnosis of gastrointestinal stromal tumors, and immunohistochemical detection of CD117 and/or DOG-1 positive;
• According to the modified RECISTv1.1-GIST-specific (hereinafter referred to as"mRECIST") criteria, the subject has at least one measurable lesion (the long diameter of non-lymph node lesions is ≥ 1.0 cm or ≥ 2 times the scanning slice thickness); the lesions with definite progression after local treatment can also be considered as measurable lesions; the imaging results must be obtained within 21 days before the first dose;
• Potentially resectable locally advanced or recurrent metastatic gastrointestinal stromal tumors who have failed imatinib treatment:
• The number of evaluable lesions is ≤ 5 as judged by CT/MRI;
• The resection is considered to have significant risks by MDT assessment (meeting any of the following):
• The maximum diameter of a single lesion is ≥ 10 cm;
• Organ function damage surgery is required (gastrectomy, total gastrectomy, hepatectomy residual liver body ≤ 50% of the normal liver volume);
• Multiple organ resection surgery is required (partial gastrectomy combined with pancreatectomy/splenectomy, pancreaticoduodenectomy and abdominoperineal resection);
• The ECOG physical status score of patients is 0-2;
• Good organ function and bone marrow reserve, including:
• Neutrophil count ≥ 1.5 × 109/L
• Hemoglobin ≥ 90 g/L
• Platelets ≥ 100 × 109/L

You may not qualify if:

• Patients with any of the following will not be enrolled in the study:
• Patients with other serious complications who cannot tolerate surgery: such as severe cardiopulmonary disease, heart function below clinical class 2, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and/or renal insufficiency, severe hepatitis and/or Child-pugh class C or B whose symptoms are significantly difficult to correct, severe malnutrition, etc.;
• Occurrence of bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery;
• Patients with severe mental illness;
• The patient has participated in or is participating in other clinical studies , or is taking other TKI agents; has any clinically significant concurrent medical condition such as uncontrolled pulmonary disease, active infection, or any other condition that, in the opinion of the investigator, may affect patient compliance, interfere with interpretation of study results, or expose the patient to safety risks.
• Active viral infections such as human immunodeficiency virus, hepatitis B, and hepatitis C
• Pregnant or lactating female patients or patients expecting to become pregnant during study treatment
• Known hypersensitivity to any component of the study drug.
• Gastrointestinal abnormalities, including but not limited to:
• Inability to swallow study drug
• Malabsorption syndrome
• Need for intravenous nutrition
• Any active bleeding, excluding hemorrhoids or gingival bleeding. Has any clinically significant concurrent medical condition, such as uncontrolled pulmonary disease, active infection, or any other condition that, in the opinion of the investigator, may affect patient compliance, interfere with interpretation of study results, or expose the patient to safety risks.
• The investigator considers that there are other factors that may affect the study results or cause the study to be terminated, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, with family or social factors that may affect the safety of patients.
• Other patients who may affect the conduct of the clinical study in the judgment of the investigator, may be unable to comply with the agreement or unable to cooperate, patients with study risks.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

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

• Hui Cao, Professor

  RenJi Hospital

  STUDY CHAIR

Central Study Contacts

Hui Cao, Professor

CONTACT

13918141425; caohuishcn@hotmail.com

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: Professor

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: November 24, 2021
• Study Start: August 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

CN (1)