A Phase 2 interventional study of Toripalimab and Liposomal doxorubicin in Undifferentiated Pleomorphic Sarcoma (UPS), sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment
This is a prospective, single-center, single-arm, open-label phase II exploratory study to evaluate the efficacy, safety, and immune remodeling effects of stereotactic body radiotherapy (SBRT) combined with reduced-dose anthracycline chemotherapy and the PD-1 inhibitor toripalimab as neoadjuvant therapy, followed by postoperative stratified maintenance therapy, in patients with localized high-risk undifferentiated pleomorphic sarcoma (UPS). A Simon two-stage design will be used, with 39 patients planned (stage 1: 13 patients; 35 patients in total, including a 10% dropout rate). Treatment consists of SBRT (8-10 Gy in 5 fractions) followed by toripalimab (240 mg intravenously every 3 weeks, 3 cycles in the neoadjuvant phase) combined with liposomal doxorubicin (30-40 mg/m² intravenously every 3 weeks, 2 cycles in the neoadjuvant phase). After response evaluation, radical surgery is performed. Postoperative stratified maintenance therapy is delivered according to pathological response: patients achieving major pathologic response (MPR) or hyalinized pathologic response (HPR) receive toripalimab monotherapy (240 mg every 3 weeks, up to 14 cycles), while those not achieving MPR/HPR receive toripalimab combined with liposomal doxorubicin (2-4 cycles). The primary endpoint is the rate of major pathologic response (MPR). Secondary endpoints include the rate of hyalinized pathologic response (HPR), radiologic objective response rate (ORR), R0 resection rate, limb salvage rate, and safety.
Undifferentiated pleomorphic sarcoma (UPS) accounts for 5-10% of soft tissue sarcomas. For localized high-risk UPS of the extremities, the standard of care is preoperative radiotherapy plus radical surgery; however, even with R0 resection, the risk of distant metastasis is 30-40% and 2-year disease-free survival is approximately 50%. The SARC028 study showed an objective response rate of 23% in UPS with pembrolizumab, and SU2C-SARC032 demonstrated that adding perioperative pembrolizumab to preoperative radiotherapy improved 2-year DFS (67% vs 52%, HR 0.61). Preclinical and clinical data suggest that stereotactic body radiotherapy (SBRT) with high dose per fraction better synergizes with immune checkpoint blockade than conventional fractionation; sparing the tumor-draining lymph nodes is critical for preserving immune priming.
This phase II study evaluates the triplet neoadjuvant regimen of SBRT, reduced-dose anthracycline chemotherapy, and toripalimab followed by postoperative stratified maintenance in patients with localized high-risk UPS. The fixed treatment schedule is: weeks 1-3 SBRT (8-10 Gy in 5 fractions, on alternate days or consecutively) plus first dose of toripalimab; week 4 first chemotherapy cycle plus second dose of toripalimab; weeks 5-6 recovery; week 7 second chemotherapy cycle plus third dose of toripalimab; weeks 8-9 recovery and response assessment; weeks 10-12 radical surgery. Postoperative maintenance begins within 4-8 weeks after surgery. Patients achieving MPR or HPR receive toripalimab monotherapy 240 mg every 3 weeks for up to 14 cycles; patients not achieving MPR/HPR receive toripalimab for 14 cycles combined with liposomal doxorubicin (2-4 cycles; 2 cycles for HPR >30%).
The sample size uses Simon's two-stage Minimax design with one-sided alpha of 0.05 and 80% power, assuming P0 = 60% and P1 = 80%. The first stage enrolls 13 patients (stop if \<=8 responders); the second stage expands to 35 patients total (declare regimen ineffective if \<=25 responders overall). Allowing for a 10% dropout rate, the planned total enrollment is 39 patients.
Efficacy assessment: pathologic response (MPR defined as \<=10% residual viable tumor cells; HPR defined as >30% hyalinization) is evaluated using a standardized pathology SOP, with confirmation by an independent central pathology laboratory. Radiologic response is evaluated by RECIST v1.1 every 12 weeks. Safety: adverse events are graded per NCI CTCAE v5.0; all adverse events are recorded up to at least 100 days after the last dose. Major wound complications are monitored within 90 days after surgery. Follow-up: visits at 30 days and 84 days after surgery, then every 3 months for survival; imaging every 12 weeks in the first year, every 24 weeks in the second year, and every 6-12 months in years 3-5; ctDNA and peripheral blood immune monitoring every 3 months for at least 2 years.
91 studies on the registry are indexed under Histiocytoma, Malignant Fibrous; 15 are open to participants now.
This study's planned enrollment of 39 is below the median of 64 across 81 interventional studies indexed under Histiocytoma, Malignant Fibrous.
Browse Histiocytoma, Malignant Fibrous studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 494 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-arm. All enrolled patients receive triplet neoadjuvant therapy: SBRT (8-10 Gy in 5 fractions, alternate days or consecutively) first, with concurrent toripalimab (240 mg IV q3w, 3 neoadjuvant cycles) plus liposomal doxorubicin (30-40 mg/m2 IV q3w, 2 neoadjuvant cycles). Radical surgery at weeks 10-12. Postoperative stratified maintenance within 4-8 weeks: MPR/HPR -\> toripalimab 240 mg q3w up to 14 cycles; non-MPR/HPR -\> toripalimab q3w 14 cycles plus liposomal doxorubicin 2-4 cycles (2 cycles if HPR \>30%).
Drug: Toripalimab · Drug: Liposomal doxorubicin · Radiation: Stereotactic body radiotherapy (SBRT)
Toripalimab 240 mg IV q3w; 3 neoadjuvant doses from SBRT start; maintenance up to 14 cycles until progression, death, or unacceptable toxicity.
Liposomal doxorubicin 30-40 mg/m2 IV q3w; 2 neoadjuvant cycles. Non-MPR/HPR: 2-4 adjuvant cycles (2 cycles if HPR \>30%).
SBRT 8-10 Gy x 5 (median 8 Gy x 5), over 5-10 days in weeks 1-3, IGRT required.
Rate of Major Pathologic Response (MPR)
Time frame: At surgery
Rate of Hyalinized Pathologic Response (HPR)
Time frame: At surgery
Objective Response Rate (ORR)
Time frame: After completion of neoadjuvant therapy, before surgery (approximately weeks 8-9 after enrollment)
R0 Resection Rate
Time frame: At surgery
Limb Salvage Rate
Time frame: At surgery
Adverse Events
Time frame: From the first dose of study treatment until at least 100 days after the last dose
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Toripalimab
Histiocytoma, Malignant Fibrous →
Tianjin Medical University Cancer Institute and Hospital →