Gastrointestinal Stromal Tumor(GIST)Phase 2NCT04633122

A Study to Assess DCC-2618 and Sunitinib in Patients With Advanced GIST After Treatment With Imatinib

A Phase 2 study testing Ripretinib and Sunitinib in people with Gastrointestinal Stromal Tumor(GIST), run by Zai Lab (Shanghai) Co., Ltd. at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastrointestinal Stromal Tumor(GIST)
What is being tested?: Ripretinib and Sunitinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 18 sitesChina
Study dates: 25 Nov 2020to 20 Jul 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients ≥18 years of age.
Histological diagnosis of advanced GIST and capability of providing tumor tissue sample (the interval between tumor tissue collection and signing of informed consent form should be less than 3 years). Otherwise, biopsy is required.
Provide molecular test report with KIT/PDGFRA mutation status prior to randomization.
Patients must have progressed on imatinib or have documented intolerance to imatinib. Subjects must have discontinued imatinib treatment 10 days prior to the first dose of the study drug. All prior imatinib treatments will be considered as first-line (such as imatinib adjuvant therapy and imatinib dose increase).
ECOG PS of 0-2.
Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening.

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Patients of reproductive potential must agree to follow the contraception requirements.
At least 1 measurable lesion according to the "RECIST v1.1-GIST-specific Criteria" (non-nodal lesions must be ≥1.0 cm in the long axis or ≥ double the slide thickness in the long axis) ; obtaining radiographic image results within 28 days prior to the first dose of study drug.
Good organ function and bone marrow reserve function, including:
Neutrophil count ≥ 1,000/µL
Hemoglobin ≥ 8 g/dL
Platelet count ≥ 75,000/µL
Total bilirubin ≤ 1.5 × the upper limit of normal (ULN)
AST and ALT ≤ 3×ULN, and AST and ALT≤ 5×ULN in the presence of hepatic metastases
Creatinine clearance ≥ 50 mL/min (based on Cockcroft-Gault estimation Formulas for calculation)
Prothrombin time (PT), international normalized ratio (INR) or partial thromboplastin time ≤ 1.5 × ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to study drug administration may have PT/INR measurements >1.5 × ULN if, in the opinion of the investigator, the patient is suitable for the study. An adequate rationale must be provided to the sponsor prior to randomization.
Resolution of all toxicities from prior therapy to ≤Grade 1 (or baseline) within 1 week prior to the first dose of study drug (excluding alopecia and ≤ Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities).
Patient is capable of understanding and complying with the protocol. Subjects should sign the written informed consent before any study-related procedures were performed.

Who cannot join

Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line treatment should not be enrolled.
Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible.
Patient has known active central nervous system metastases.
New York Heart Association class II - IV heart disease, myocardial infarct, active ischemia or any other uncontrolled cardiac condition within the first 6 months of the first dose of study drug such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
Left ventricular ejection fraction (LVEF) < 50%.
Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.

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Venous thrombotic events (e.g. deep vein thrombosis) or pulmonary arterial events (e.g. pulmonary embolism) within 1 month before the first dose of study drug. Patients on stable anticoagulation therapy for at least one month are eligible.
12-lead electrocardiogram (ECG) demonstrating QT interval corrected by Fridericia's formula > 450 ms in males or > 470 ms in females at screening or history of long QT interval syndrome.
Use of strong or moderate inhibitors and/or inducers of cytochrome P450 (CYP) 3A4 within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug, including certain herbal medications (eg, St. John's Wort) and consumption of grapefruit or grapefruit juice within 14 days prior to the first dose of study drug.
Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
Major surgeries (e.g. abdominal laparotomy) within 4 weeks of the first dose of study drug; all major surgical wounds must be healed and free of infection or dehiscence before the first dose of study drug.
Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, 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.
Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, hepatitis B virus (HBV) DNA > 2000 IU/ml or > 104 copies/ml.
Female patients who are pregnant or lactating or who plan to become pregnant during the study treatment period.
Known hypersensitivity to any component of the study drug. Patients with Stevenson Johnson syndrome in previous TKI treatment need to be excluded.
Gastrointestinal abnormalities including but not limited to:
inability to take oral medication
malabsorption syndrome
Requiring intravenous nutrition
Any active hemorrhages, excluding hemorrhoids or gum bleeding.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

China18 sites

Beijing Cancer Hospital
Beijing, Beijing Municipality
Chinese PLA General Hospital
Beijing, Beijing Municipality
The General Hospital of Peking University
Beijing, Beijing Municipality
West China Hospital of Sichuan University
Chengdu, Sichuan
The First Affiliated Hospital of Chongqing Medical Universty
Chongqing, Chognqing
Fujian Medical University Union Hospital
Fuzhou, Fujian
The Cancer Hospital of Sun Yat-sen University
Guangzhou, Guangdong
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
The sixth Affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
The Affiliated Hospital of Haerbin MedicalUniversity
Harbin, Heilongjiang
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality
Fudan University, Zhongshan Hospital
Shanghai, Shanghai Municipality
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
The 4th Hospital of Hebei Medical University
Shijiazhuang, Hebei
The Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Union Hospital of HUST
Wuhan, Hubei

Other trials in China

About this study

Official title: A Phase 2, Randomized, Multicenter, Open-label Study of DCC-2618 (Ripretinib, ZL-2307 ) vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With 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.

Conditions: Gastrointestinal Stromal Tumor(GIST)
Being tested: Ripretinib, Sunitinib
Keywords: Gastrointestinal Stromal Tumors,GIST,DCC-2618,Ripretinib
Medical subject headings: Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RipretinibDrug
Also called DCC-2618
Oral kinase inhibitor
SunitinibDrug
second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib

Study groups in NCT04633122
Study group	Role	What they receive
Ripretinib	Experimental	50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle. Receives: Drug: Ripretinib
Sunitinib	Active comparator	12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break. Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free Survival (PFS)
PFS is defined as the time interval from randomization to the first occurrence of progressive disease based on assessment of the independent radiology review (IRR) or death due to any causes.
Measured: Approximately 12 months.

Secondary outcomes (2)

Objective Response Rate (ORR)
The percentage of participants whose efficacy is confirmed as complete response (CR) or partial responses (PR) based on independent radiology review.
Measured: Approximately 12 months.
Disease Control Rate (DCR)
The percentage of participants whose efficacy is confirmed as complete response (CR) or partial responses (PR) or duration of SD ≥ 12 months based on independent radiology review.
Measured: Approximately 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Nov 202020 Jul 2022

First posted18 Nov 2020
Study start25 Nov 2020
Primary completion20 Jul 2022
Study completion20 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gastrointestinal Stromal Tumor(GIST)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04633122
Sponsor's protocol ID: ZL-2307-003
Status last verified: Dec 2024
First submitted: 11 Nov 2020
Last updated: 3 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Multicenter, Open-label Study of DCC-2618 (Ripretinib, ZL-2307 ) vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumors After Treatment With Imatinib
ClinicalTrials.gov ID: NCT04633122
Acronym / sponsor ID: ZL-2307-003
Conditions: Gastrointestinal Stromal Tumor(GIST)
Keywords: Gastrointestinal Stromal Tumors,GIST,DCC-2618,Ripretinib
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Nov 2020 (actual)
Primary completion: 20 Jul 2022 (actual)
Study completion: 20 Jul 2022 (actual)
First posted: 18 Nov 2020 (actual)
Results: Posted 15 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ripretinib	Experimental	Drug: Ripretinib50mg/tablet,150 mg QD continuous administration, 6 weeks (42 days) for a cycle.
Sunitinib	Active comparator	Drug: Sunitinib12.5mg/capsule, 50 mg QD, in 6 weeks (42 days) with 4 weeks continuous dosing followed by 2 weeks break.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Male or female patients ≥18 years of age.
Histological diagnosis of advanced GIST and capability of providing tumor tissue sample (the interval between tumor tissue collection and signing of informed consent form should be less than 3 years). Otherwise, biopsy is required.
Provide molecular test report with KIT/PDGFRA mutation status prior to randomization.
Patients must have progressed on imatinib or have documented intolerance to imatinib. Subjects must have discontinued imatinib treatment 10 days prior to the first dose of the study drug. All prior imatinib treatments will be considered as first-line (such as imatinib adjuvant therapy and imatinib dose increase).
ECOG PS of 0-2.

Key exclusion criteria (20 listed)

Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line treatment should not be enrolled.
Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible.
Patient has known active central nervous system metastases.
New York Heart Association class II - IV heart disease, myocardial infarct, active ischemia or any other uncontrolled cardiac condition within the first 6 months of the first dose of study drug such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
Left ventricular ejection fraction (LVEF) < 50%.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RipretinibAlso: DCC-2618Oral kinase inhibitor	Drug	Ripretinib
Sunitinibsecond-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib	Drug	Sunitinib

Primary outcome

Progression-free Survival (PFS)
Time frame: Approximately 12 months.
PFS is defined as the time interval from randomization to the first occurrence of progressive disease based on assessment of the independent radiology review (IRR) or death due to any causes.

2 secondary outcomes

Objective Response Rate (ORR)
Time frame: Approximately 12 months.
Disease Control Rate (DCR)
Time frame: Approximately 12 months.

Results and safety

Results posted to the registry on 15 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ripretinib	54	13
Sunitinib	54	15

Primary outcome: Progression-free Survival (PFS)

Time frame: Approximately 12 months.. Median (95% Confidence Interval). Unit: months

Measure	Ripretinib n = 54	Sunitinib n = 54
Value	10.3 (5.5 to NA)	8.3 (4.9 to NA)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ripretinib	9 of 54 (16.7%)	54 of 54 (100%)	13 of 54
Sunitinib	12 of 54 (22.2%)	54 of 54 (100%)	15 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ripretinib and Sunitinib in people with Gastrointestinal Stromal Tumor(GIST), run by Zai Lab (Shanghai) Co., Ltd. at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Approximately 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04633122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.