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Elemene combined with imatinib in the treatment of first-line therapy failure gastrointestinal stromal tumors: a single-arm, open phase II trial

Elemene combined with imatinib in the treatment of first-line therapy failure gastrointestinal stromal tumors: a single-arm, open phase II trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063703
Enrollment
Unknown
Registered
2022-09-15
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal stromal tumors

Interventions

Group 1 :elemene combined with imatinib

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient is 18-75 years old, male or female, and signs an informed consent form; 2. Patients with gastrointestinal stromal tumors confirmed by histopathology; 3. There are measurable lesions or observable imaging data such as CT and MRI; 4. First-line imatinib treatment failed; 5. KPS score >= 60; 6. The estimated survival time is >= 3 months; 7. Hemogram: RBC >= 3.0 x 10^12/L, WBC >= 3.5 x 10^9/L, ANC >= 1.5 x 10^9/L, PLT >= 100 x 10^9/L, HB >= 90 g/L; 8. Renal function: Cr <= 1.2 x UNL (upper limit of normal value); 9. Liver function: total bilirubin <= 1.5 x UNL; ALT, AST <= 1.5 x UNL.

Exclusion criteria

Exclusion criteria: 1. Allergic constitution, those who are known to be allergic to the components of this medicine; 2. Patients with high fever and acute infection; 3. Patients with progressive bleeding; 4. Important organs have primary diseases; 5. Participated in any clinical trial of research drugs within 4 weeks before enrollment; 6. Patients with mental or physical disabilities; 7. Suspect or have a history of alcohol and drug abuse; 8. Combined with other chemotherapy and traditional Chinese medicine anti-tumor therapy during the study administration period; 9. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Disease control rate;

Secondary

MeasureTime frame
Objective response rate;Progressive-free survival;Overall survival;Qualify of life;

Countries

China

Contacts

Public ContactXiaojun Wu

Sun Yat-sen University Cancer Center

wuxj@sysucc.org.cn+86 13924179417

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026