Preoperative IMRT With Anlotinib and Penpulimab for Localized Sarcoma (SPARE-01)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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 and Penpulimab for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age older than 18-yo

Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.

ECOG 0-3

Histology reviewed by reference pathologist

Disqualifiers

No gross tumor post-resection in other center.

Contraindications to Anlotinib, including allergic to Anlotinb, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.

Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.

Benign histology

Trial design

Design model

Single group

Treatments tested in this trial

  • Anlotinib hydrochloride

    Drug

    Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Anlotinib and Penpulimab armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major wound complications

Time frame
4-months post-surgery

Secondary outcomes

1

Acute and late toxicities

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time frame
acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months
2

Quality of Life

Evaluate quality of life by QOL questionnaires at different time points

Time frame
pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up
3

Extremity function

Evaluate quality of life by MSTS forms at different time points

Time frame
pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up
4

Pathological remission rate

evaluate the tumor remission rate microscopically

Time frame
2 weeks after operation

Other outcomes

Sponsors and contacts

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