Could a drug cocktail shrink sarcomas before surgery?
NCT ID NCT05167994
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether giving a drug called anlotinib (which cuts off tumor blood supply) along with immunotherapy (penpulimab) and radiation before surgery can improve outcomes for people with soft tissue sarcoma in the arms, legs, or trunk. The study will enroll 30 adults and focus on safety, wound complications, and quality of life. It is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- anlotinib hydrochloride (a drug that blocks blood vessel growth) and penpulimab (an immunotherapy drug)
- What this could lead to
- If successful, this combination could improve tumor shrinkage before surgery and reduce wound complications for people with soft tissue sarcoma.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply widely. The combination may increase side effects like wound healing problems or toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2020
- Expected to finish
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Dec 2027
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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18 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: * 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.
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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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Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, 100021, China
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Other studies related to the condition(s) this trial covers.
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- Can light and sound replace X-Rays? a new imaging method aims to see inside without radiation
- Could a condensed radiation course after cervical cancer surgery be just as safe and effective?
- Cancer-Killing virus injected directly into tumors shows promise in Mid-Stage trial
- New drug cocktail aims to shrink lung tumors before surgery
- New drug combo shows promise for rare sarcoma