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A prospective, open, one-arm, multi-center clinical study on the efficacy and safety of Shouzu Ning Decoction for the treatment of grade III hand-foot syndrome caused by apatinib

A prospective, open, one-arm, multi-center clinical study on the efficacy and safety of Shouzu Ning Decoction for the treatment of grade III hand-foot syndrome caused by apatinib

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800020113
Enrollment
Unknown
Registered
2018-12-14
Start date
2019-07-06
Completion date
Unknown
Last updated
2019-07-29

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

Conditions

Hand-foot Syndrome

Interventions

Case series:TCM

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age is greater than 18 years old, male and female; 2. Patients with grade III hand-foot syndrome caused by apatinib alone; 3. Grade III hand-foot syndrome according to NCI-CTC 5.0 standard; 4. KPS > 60; 5. The functional level of major organs meets the following criteria: 1) ANC (> 1.5 *10^9/L), PLT (> 80 *10^9/L), Hb (> 90 g/L); 2) TBIL 50 ml/min) (Cockcroft-Gault formula); 6. Subjects volunteered to join the study and signed the informed consent. Willing to and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion criteria

Exclusion criteria: 1. Those with hand-foot skin lesions or history of allergy to drugs; 2. Use other medications that can cause hand-foot syndrome at the same time, such as capecitabine, docetaxel, etc.; 3. Uncontrolled infections and metabolic diseases; 4. Coagulant function abnormality, with bleeding tendency or is treated with thrombolysis and anticoagulation; 5. Other situations that the researchers considered unsuitable for this study.ble for this study.

Design outcomes

Primary

MeasureTime frame
The duration of remission and the total effective rate (including symptoms remission and disappearance;

Secondary

MeasureTime frame
The time and recurrence rate of grade III hand-foot syndrome recurred within one month after the hand-foot syndrome was reduced to grade I or the symptoms disappeared completely;Safety;completion rate of original dose intensity;

Countries

China

Contacts

Public ContactQijin Shu

The First Affiliated Hospital of Zhejiang Chinese Medical University

shuqjhz@163.com+86 13605706566

Outcome results

None listed

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