Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Imatinib Mesylate

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle.

12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break.

Ripretinib

second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib

the primary objective of this study is to assess the efficacy (progression-free survival,PFS) of DCC-2618 (ripretinib, ZL-2307) and sunitinib in patients with advanced gastrointestinal stromal tumors after treatment with imatinib. This study will enroll approximately 98 subjects in around 18 sites in China mainland, and all subjects will be receiving DCC-2618 or Sunitinib in equal chance as treatment.

A Study to Assess the Efficacy and Safety of DCC-2618 and Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib

A Multicenter Phase 2, Single-Arm Open-Label Study of DCC-2618 to Assess Efficacy, Safety, and Pharmacokinetics In Patients With Advanced Gastrointestinal Stromal Tumors Who Have Progressed On Prior Anticancer Therapies

To assess the efficacy (progression-free survival \[PFS\], by independent radiologic review)of DCC-2618 (ripretinib, ZL-2307) and sunitinib in patients

To assess objective response rate (ORR) by independent radiologic review using RECIST v1.1-GIST-specific criteria

To assess disease control rate (DCR) by independent radiologic review

To assess PFS based on Investigator assessment

* Incidence of treatment emergent adverse event (TEAE), adverse event of special interest (AESI) and serious adverse event (SAE); severity of adverse event will be assessed (based on NCI CTCAE 5.0);
* Incidence of adverse events resulting in dose adjustment of the study drug or termination of the study

Zai Lab (Shanghai) Co., Ltd.

For subjects who achieved PR or SD, perform resection of gastrointestinal stromal tumor

oral administration of Ripretinib 150 mg QD. Resection of gastrointestinal stromal tumors was performed in patients who achieved PR or SD

Resection surgery of gastrointestinal stromal tumor

Minghui Pang, Professor

The objective of this observational study is to explore the efficacy and safety of ripretinib treatment combined with surgery in advanced gastrointestinal stromal tumors(GIST) after failure of imatinib therapy.

This study is a single-arm, multicenter, observational study. A total of approximately 30 subjects were be enrolled. The patient was orally administered with ripretinib150 mg QD. 4 weeks for one cycle. Efficacy was assessed every two cycles. For subjects with PR or SD after ripretinib treatment, resection of gastrointestinal stromal tumor was performed after discussion by MDT and ensure R0 resection as much as possible.Ripretinib 150mg QD was continued 2 weeks after surgery. Thereafter, subjectss entered the follow-up period for at least 1 year. Safety and survival information will be collected

Ripretinib Combined With Surgery in Advanced GIST That Have Failed Imatinib Therapy: A Multicenter,Observational Study

Ripretinib Combined With Surgery in Advanced Gastrointestinal Stromal Tumors That Have Failed Imatinib Therapy: A Multicenter,Observational Study

PFS Based on radiographic assessment using Choi criteria

Objective response rate as determined by confirmed CR + confirmed PR by radiologic review

R0 is the proportion of subjects with no microscopic residual after resection

Proportion of subjects with an overall survival time of at least 2 years

The time from the start of treatment to the progression

Sichuan Provincial People's Hospital

Professor

Exanthema

Skin Diseases

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisone

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

prednisone 30mg/day 3weeks oral, if on rash or pruritus prednisolone 20mg/day 3weeks -\> 10mg/day-\>7.5mg/day-\>5mg/day-\>stop

Prednisone treatment for severe skin rash induced by imatinib

Yoon-Koo Kang, MD, PhD

To achieve optimal clinical outcomes with imatinib in GIST patients, it is crucial to maintain standard imatinib dose. Skin rash is a relatively common and sometimes severe adverse event of imatinib in GIST patients and may affect imatinib compliance. Our previous retrospective study suggested that severe skin rash induced by imatinib can be managed by systemic steroid without imatinib dose interruption or reduction. This phase II study was conducted to evaluate the efficacy and safety of systemic steroid in GIST patients with imatinib-associated severe skin rash.

Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor

Treatment success was defined as maintaining imatinib without persistence or recurrence of skin rash requiring 1) additional systemic steroid treatment, and 2) interruption or dose reduction of imatinib.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Assess the Efficacy and Safety of DCC-2618 and Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib	NCT04633122	Gastrointestina...	Ripretinib Sunitinib	18 Years -	Zai Lab (Hong Kong), Ltd.
Ripretinib Combined With Surgery in Advanced GIST That Have Failed Imatinib Therapy: A Multicenter,Observational Study	NCT05354388	Gastrointestina...	Resection surge...	18 Years - 75 Years	Sichuan Provincial People's Hospital
A Study to Assess the Efficacy and Safety of DCC-2618 and Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib	NCT04633122	Gastrointestina...	Ripretinib Sunitinib	18 Years -	Zai Lab (Hong Kong), Ltd.
Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor	NCT03440515	Gastrointestina...	Prednisone	18 Years -	Asan Medical Center
Management of Imatinib-associated Severe Skin Rash in Patients With Gastrointestinal Stromal Tumor	NCT03440515	Gastrointestina...	Prednisone	18 Years -	Asan Medical Center

Spots Global Cancer Trial Database for gastrointestinal stromal tumor(gist)