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Not yet taking people in ChinaPhase 2

Radiotherapy with anlotinib, with or without penpulimab, before surgery for soft tissue sarcoma

Tests radiotherapy plus anlotinib, with or without penpulimab, before surgery in soft tissue sarcoma.

Key facts

Who runs it
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Where
Beijing, ChinaSee the site
Trial code
Registry title
Preoperative Radiotherapy and Anlotinib With or Without Penpulimab for Soft Tissue Sarcoma
Status
Not yet recruiting
Phase
Phase 2
People taking part
274 people, planned
Started
1 Jul 2026
Expected to end
31 Dec 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Anlotinib
  • Penpulimab
  • Preoperative Radiotherapy
  • Surgery
Record updated
28 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 15 or older with soft tissue sarcoma of an arm, leg or the trunk who need radiotherapy before surgery.

Age
15 years or older
Sex
All sexes can join.
Disease stage
Primary or recurrent soft tissue sarcoma of the extremity or trunk, intermediate- to high-grade, with tumor size >=5 cm (2 in) or a deep-seated tumor. Histologically confirmed, with at least one lesion that can be measured.
Earlier treatment
No earlier radiotherapy to the same body area. People whose tumor was removed in an unplanned operation at another hospital must still have visible tumor left.

Main reasons for not taking part

  • Prior radiotherapy to the same anatomical site
  • Autoimmune disease, active bleeding, ulcer, intestinal perforation or obstruction, uncontrolled hypertension, or severe heart, liver or kidney problems
  • Dermatofibrosarcoma protuberans, desmoid fibromatosis, tenosynovial giant cell tumor, benign tumors, or well-differentiated liposarcoma
  • Embryonal rhabdomyosarcoma or Ewing sarcoma
  • A new cancer in the last 5 years, with a few early-stage exceptions

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Benign tumors
  • Lipoma-like liposarcoma or well-differentiated liposarcoma
  • Soft tissue sarcoma that can be cured by wide local excision alone

Where in China

  • Cancer Hospital, National Cancer Center, CAMS & PUMCBeijing, ChinaContact: Ning-Ning LuNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Arm A: Preoperative Radiotherapy Plus AnlotinibExisting treatment, for comparison

    Preoperative Radiotherapy Plus Anlotinib

    Treatment: Anlotinib, Preoperative Radiotherapy, and Surgery

  • Arm B: Preoperative Radiotherapy Plus Anlotinib and PenpulimabTreatment being tested

    Preoperative Radiotherapy Plus Anlotinib and Penpulimab

    Treatment: Anlotinib, Penpulimab, Preoperative Radiotherapy, and Surgery

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective Multicenter Randomized Controlled Study of Preoperative Radiotherapy Combined With Targeted Therapy With or Without Immunotherapy for Soft Tissue Sarcoma
Plain-language title
Radiotherapy with anlotinib, with or without penpulimab, before surgery for soft tissue sarcomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 May 2026