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Efficacy and Safety of Anlotinib in Adjuvant Therapy for High-grade Soft Tissue Sarcoma

NCT03951571 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-05-14

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Anlotinib Hydrochloride Capsule combined with Best Supportive Therapy in the adjuvant treatment of patients with high-grade soft tissue sarcoma after operation, as compared with placebo combined with Best Supportive Therapy.

Conditions

  • Soft Tissue Sarcoma Adult
  • High Grade Sarcoma

Interventions

DRUG

Anlotinib Hydrochloride

Before breakfast, take an Anlotinib hydrochloride placebo once a day, 12 mg (1 pill) at a time. Continuous oral administration for two weeks and stop for one week. Three weeks (21 days) for a treatment cycle. The total treatment cycles is six.

DRUG

Placebo Oral Tablet

Before breakfast, take an placebo once a day, 1 pill at a time. Continuous oral administration for two weeks and stop for one week. Three weeks (21 days) for a treatment cycle. The total treatment cycles is six.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Wangjun Yan · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2022-06-01
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03951571 on ClinicalTrials.gov