Could adding immunotherapy to Pre-Sarcoma treatment boost survival?
NCT ID NCT07612098
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding an immunotherapy drug (penpulimab) to standard pre-surgery radiation and a targeted therapy (anlotinib) can help people with soft tissue sarcoma live longer without the cancer coming back. About 274 adults with intermediate- to high-grade sarcoma in an arm, leg, or trunk will take part. The goal is to see if the three-drug combo improves 3-year disease-free survival compared to the two-drug combo.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 274 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * No gross tumor remaining after unplanned tumor resection performed at another hospital. * 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. * Benign tumors. * Sarcoma subtypes for which chemotherapy is recommended as the preferred neoadjuvant treatment according to guidelines, such as embryonal rhabdomyosarcoma or Ewing sarcoma. * Lipoma-like liposarcoma or well-differentiated liposarcoma. * 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. * Soft tissue sarcoma that can be cured by wide local excision alone. * Prior radiotherapy to the same anatomical site. * Other severe medical comorbidities that would preclude surgery or participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Hospital, National Cancer Center, CAMS & PUMC
Beijing, Beijing Municipality, 100021, China
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Other studies related to the condition(s) this trial covers.
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- Can a Dual-Target drug crack resistant gynecologic and breast cancers?
- Can a smart drug hunt down sarcoma cells without harming healthy ones?
- Can a Patient's own immune cells fight advanced sarcoma?
- Smartwatch exercise plan aims to rebuild fitness in young cancer survivors
- Can tailored exercise help young sarcoma survivors recover strength?