New combo therapy aims to improve sarcoma surgery outcomes
NCT ID NCT07396116
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial is testing whether giving a special type of radiation (ultra-hypofractionated) along with immunotherapy before surgery is safe and feasible for people with retroperitoneal sarcoma. The study will enroll 28 participants. The main goal is to see how many patients have complications around the time of surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ultra-hypofractionated radiotherapy combined with immunotherapy
- What this could lead to
- If successful, this could point toward a new treatment approach that improves surgical outcomes for retroperitoneal sarcoma.
- What could go wrong
- This is a very early, small trial (28 people) focused on safety, not effectiveness. The combination may increase side effects or not improve outcomes.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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: * Diagnosis \& Indication: Primary or recurrent abdominopelvic soft tissue sarcoma. Patients are deemed to have a high probability of R1/R2 resection with upfront surgery and are confirmed to require radiotherapy following Multidisciplinary Team (MDT) discussion. * Target Volume: In cases of multifocal disease, all lesions must be safely encompassable within a single radiotherapy target volume. * Age: Age ≥ 18 years. * Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status 0-2; American Society of Anesthesiologists (ASA) score ≤ 2; patients must be expected to tolerate surgery and radiotherapy. * Pathology: Histologically confirmed soft tissue sarcoma. * Measurability: Presence of evaluable lesions. * Life Expectancy: Life expectancy \> 5 years. * Hematological \& Hepatic Function: Adequate organ function * Renal Function: Adequate renal function defined as Glomerular Filtration Rate (GFR) ≥ 50 ml/min (calculated by Cockcroft-Gault formula), and split renal function imaging confirms function in the contralateral kidney. * Contraception: Female patients of childbearing potential, or male patients with female partners of childbearing potential, must agree to use effective contraception during the entire treatment period and for 6 months after the last dose. * Consent: Signed informed consent form. * Follow-up: Capable of complying with follow-up requirements. Exclusion Criteria: * Significant Comorbidities: Patients with the following concurrent conditions: active hemorrhage, ulceration, intestinal perforation, intestinal obstruction, uncontrolled hypertension, cardiac insufficiency (NYHA Class III-IV), severe hepatic or renal dysfunction (Grade 4), mesenteric ischemia, or severe inflammatory bowel disease (IBD). * Excluded Histologies: Other pathological types, including Gastrointestinal Stromal Tumor (GIST), sarcomatoid carcinoma, sarcomas primarily treated with chemotherapy (e.g., rhabdomyosarcoma and PNET), desmoid fibromatosis, and benign tumors. * Unresectability: Tumor invasion into critical structures such as the liver, pancreatic head, or abdominal aorta, rendering the tumor deemed unresectable. * Prior Radiotherapy: History of prior radiotherapy to the same anatomical region. * Distant Metastasis: Presence of distant metastasis (M1) confirmed by comprehensive imaging/examination within 4 weeks prior to enrollment. * Contraindications to Surgery/Protocol: Presence of other severe medical comorbidities that contraindicate surgery or preclude participation in the study. * Planned Neoadjuvant Chemotherapy: Patients scheduled to receive (concurrent) neoadjuvant chemotherapy. * Recent Systemic Therapy: Receipt of chemotherapy or other systemic treatments within 4 weeks prior to enrollment.
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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
Beijing, Beijing Municipality, 100021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can precision radiation and immunotherapy team up against abdominal colorectal cancer?
- Can an oral drug that starves tumors help Hard-to-Treat cancers?
- Can a Dual-Target drug crack resistant gynecologic and breast cancers?
- Can a Three-Dose immunotherapy cure early lung cancer without surgery?
- Can a smart drug hunt down sarcoma cells without harming healthy ones?
- MRI 'Fingerprint' may reveal which head and neck tumors vanish with Pre-Surgery therapy