Anlotinib, Extremity, Intensity-modulated Radiotherapy, Major Wound Complications, Sarcoma,Soft Tissue, Trunk
Conditions
Brief summary
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.
Interventions
DRUGAnlotinib hydrochloride
Anlotinib 12mgQD, from D1 of pre-operative IMRT to 1 month after end of IMRT
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing Jishuitan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Lesion can be assessed * Can tolerate radiotherapy and Anlotinib * Agree contraception. * Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
Exclusion criteria
* 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 * Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma) * STS can be cured by extensive operation alone. * Previous irradiation to the same area * Radiological evidence of distant metastases * Other contraindications, can't tolerate operation or other treatment needed in this study. * Neoadjuvant chemotherapy given or planned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major wound complications | 4-months post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute and late toxicities | acute toxicities were evaluated during and 3 months after IMRT, late toxicities were evaluted after 6 months | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| Quality of Life | pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up | Evaluate quality of life by QOL questionnaires at different time points |
| Extremity function | pre-IMRT, end of IMRT, 1 months post-IMRT, and every 3 to 6 months during follow-up | Evaluate quality of life by MSTS forms at different time points |
| Pathological remission rate | 2 weeks after operation | evaluate the tumor remission rate microscopically |
| Local control | 2-year | — |
| Overall Survival | 2-year | — |
Countries
China
Contacts
CONTACTNing-Ning Lu
Outcome results
None listed