NCT05167994 (SPARE-01) is a Phase 2 clinical trial of Anlotinib hydrochloride in Sarcoma,Soft Tissue, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Who is sponsoring NCT05167994?

NCT05167994 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

What drugs are being tested in NCT05167994?

Interventions in NCT05167994: Anlotinib hydrochloride.

What condition does NCT05167994 study?

NCT05167994 studies Sarcoma,Soft Tissue, Extremity, Trunk, Anlotinib, Intensity-modulated Radiotherapy, Major Wound Complications.

Is NCT05167994 still recruiting?

NCT05167994 is currently recruiting now. Last updated 11 December 2025.

Last reviewed 2025-12-11 · How we verify

NCT05167994: SPARE-01

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Preoperative IMRT With Concurrent Anlotinib for Localised Extremity or Trunk Sarcoma （SPARE-01）

Recruiting now Phase 2 Last updated 11 December 2025

What this trial tests

Phase 2 trial testing Anlotinib hydrochloride in Sarcoma,Soft Tissue in 30 participants. Currently enrolling.

Timeline

1 May 2020

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 May 2020
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	1 location across China

Drugs / interventions tested

Anlotinib hydrochloride

Conditions studied

Sarcoma,Soft Tissue — all drugs for Sarcoma,Soft Tissue →
Extremity — all drugs for Extremity →
Trunk — all drugs for Trunk →
Anlotinib — all drugs for Anlotinib →

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

18 and older, any sex, with Sarcoma,Soft Tissue or Extremity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Predicting pathological complete response of neoadjuvant radiotherapy and targeted therapy for soft tissue sarcoma by whole-tumor texture analysis of multisequence MRI imaging.
Miao L, Cao Y, Zuo L, Zhang H, et al · · 2023 · cited 30× · PMID 36580095 · DOI 10.1007/s00330-022-09362-6
Habitat escalated adaptive therapy (HEAT): a phase 2 trial utilizing radiomic habitat-directed and genomic-adjusted radiation dose (GARD) optimization for high-grade soft tissue sarcoma.
Naghavi AO, Bryant JM, Kim Y, Weygand J, et al · · 2024 · cited 10× · PMID 38594603 · DOI 10.1186/s12885-024-12151-7
Tumor habitat characteristics derived from intravoxel incoherent motion for early response assessment in soft tissue sarcoma undergoing neoadjuvant radiotherapy and targeted therapy: a phase II study.
Wen X, Jiang J, Miao L, Yang Z, et al · · 2026 · PMID 41815116 · DOI 10.21037/tcr-2025-aw-2201

Verify or expand the search:

Other trials of Anlotinib hydrochloride

Trials testing the same drug.

NCT06476093 — SRT Combined With Anlotinib for the Treatment of Brain Metastases From Non-small Cell Lung Cancer · NA · recruiting
NCT05193188 — A Study of Anlotinib Combined With or Without PD-1 Antibody on Unresectable High-grade Chondrosarcoma · Phase 2 · unknown
NCT05539118 — Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma · Phase 1, PHASE2 · not yet recruiting
NCT05883085 — A Study on the Safety and Effectiveness of Anlotinib for Neoadjuvant Treatment of PPGL · Phase 2 · unknown
NCT04952493 — Anlotinib or Penpulimab in Combination With RAI for DTC · Phase 2 · unknown

Other recruiting trials for Sarcoma,Soft Tissue

Currently open trials in the same condition.

NCT06835049 — Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue · Phase 2 · recruiting
NCT07066982 — Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas · Phase 1, PHASE2 · recruiting
NCT06660810 — Neoadjuvant Intralesional Injection of Talimogene Laherparepvec · Phase 2 · active not recruiting
NCT06637007 — Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma · Phase 2 · recruiting
NCT05813327 — Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma · Phase 1 · active not recruiting

Other Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials

Trials by the same sponsor.

NCT07531563 — Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy · NA · not yet recruiting
NCT07537049 — BR101 in Patients With Relapsed/Refractory Multiple Myeloma · Phase 1 · not yet recruiting
NCT07187154 — The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy · NA · not yet recruiting
NCT07530549 — A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Che · Phase 2 · not yet recruiting
NCT07507058 — Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05167994 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Last refreshed: 11 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05167994.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing