NCT07612098Not yet recruitingPhase 2
Preoperative Radiotherapy and Anlotinib With or Without Penpulimab for Soft Tissue Sarcoma
A Prospective Multicenter Randomized Controlled Study of Preoperative Radiotherapy Combined With Targeted Therapy With or Without Immunotherapy for Soft Tissue Sarcoma
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
Soft tissue sarcoma is a rare cancer that often requires surgery combined with radiotherapy. Preoperative radiotherapy can improve the chance of complete tumor removal and limb preservation, but some patients still experience local recurrence, distant metastasis, or poor tumor response. This is a prospective, multicenter, randomized phase II study for patients with localized soft tissue sarcoma of the extremity or trunk who need preoperative radiotherapy. Participants will be randomly assigned to receive preoperative radiotherapy plus anlotinib, or preoperative radiotherapy plus anlotinib and penpulimab. Surgery will be performed after completion of neoadjuvant treatment according to the study protocol. The main purpose of this study is to evaluate whether adding penpulimab to preoperative radiotherapy and anlotinib can improve 3-year disease-free survival. The study will also assess pathological response, wound complications, treatment-related adverse events, local control, distant metastasis-free survival, overall survival, limb function, quality of life, and exploratory biomarkers related to treatment response.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 274 (estimated)
- First submitted
- 21 May 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT07612098
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 274
- From 1 Jul 2026 to the primary completion date, 31 Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No gross tumor remaining after unplanned tumor resection performed at another hospital.
- Sarcoma subtypes for which chemotherapy is recommended as the preferred neoadjuvant treatment according to guidelines, such as embryonal rhabdomyosarcoma or Ewing sarcoma.
- Prior radiotherapy to the same anatomical site.
- Other severe medical comorbidities that would preclude surgery or participation in this study.
Other illness
- Contraindications to targeted therapy or immunotherapy due to comorbidities, including allergy, autoimmune disease, active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrolled hypertension, New York Heart Association class III-IV cardiac dysfunction, or severe hepatic or renal dysfunction.
- Dermatofibrosarcoma protuberans, desmoid fibromatosis, tenosynovial giant cell tumor, or other locally aggressive diseases.
- New malignant tumor within 5 years before enrollment, except cervical carcinoma in situ, early-stage basal cell carcinoma of the skin, or early-stage lung cancer.
Other
- Benign tumors.
- Lipoma-like liposarcoma or well-differentiated liposarcoma.
- Soft tissue sarcoma that can be cured by wide local excision alone.
Who the study is looking for
- Primary or recurrent soft tissue sarcoma of the extremity or trunk with intermediate- to high-grade disease and tumor size \>=5 cm or deep-seated tumor, for which radiotherapy is recommended after multidisciplinary evaluation.
- Age \>=15 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
- Histologically confirmed soft tissue sarcoma.
- At least one evaluable lesion.
- Able to tolerate radiotherapy, anlotinib, and penpulimab treatment.
- Female participants of childbearing potential, or male participants with female partners of childbearing potential, must agree to use effective contraception during the treatment period and for 6 months after the last dose of study treatment.
- Able to provide written informed consent.
- Able and willing to comply with follow-up.
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, National Cancer Center, CAMS & PUMC Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.