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LeiomyosarcomaPhase 2NCT06277154

MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma

A Phase 2 study testing MASCT-I, Doxorubicin and Ifosfamide in people with Leiomyosarcoma and Liposarcoma, run by HRYZ Biotech Co. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Leiomyosarcoma, Liposarcoma, Synovial Sarcoma
What is being tested?
MASCT-I, Doxorubicin and Ifosfamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteChina
Study dates
21 Feb 2024to Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≥18 years and≤70 years;
  • According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.
  • No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.
  • At least one measurable and assessable lesion defined by RECIST 1.1;
  • ECOG performance status of 0-1;
  • Estimated life expectancy≥6 months;
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  • Pulmonary function is basically normal;
  • Subjects with organ function as defined below (any blood components and growth factors are not allowed within 14 days before apheresis): a) Hemoglobin ≥90g/L; b) Leukocyte≥3.5x10^9/L; c) The absolute neutrophil count (ANC)>1.5x10^9/L; d) Platelet≥100x10^9/L; e) ALT, AST≤2.5 ULN (Upper Limit of Normal), ALT, AST≤5 ULN for liver metastases; f) ALP≤2.5 ULN; g) Serum total bilirubin≤1.5 ULN; Patients with Gilbert's syndromes (persistent or repeated hyperbilirubinemia [mainly unconjugated bilirubin], in the absence of evidence of hemolysis or liver disease), are allowed to enroll with investigator's agreement; h) Serum urea nitrogen or urea and creatinine≤2.5 ULN; i) Serum albumin≥35g/L; j) PT, APTT, INR≤1.5 ULN (without anticoagulation treatment);
  • Obtain the written informed consent of the patient/legal representative;
  • Subjects with potential fertility must agree to use effective contraceptive measure during and within 6 months after the treatment period. HCG test for female with potential fertility must be negative before the study was included.

Who cannot join

  • Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization, or have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization.
  • Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma/hemangiopericytoma, acinous soft tissue sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor, invasive fibroma, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, etc., which are not suitable for Doxorubicin+ Ifosfamide (AI) treatment.
  • Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg/m2 doxorubicin.
  • Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.
  • Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg/day prednisone or its equivalent) and were still using them within 2 weeks before randomization.
  • Use of immunomodulators and were still using them within 2 weeks before randomization.
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  • Allergic to sodium citrate or human albumin.
  • Subjects with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.
  • Have known active central nervous system (CNS) or meningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have returned to baseline at least 2 weeks before randomization, 2) no requirement for steroids at least 2 weeks before randomization or receiving low-dose of steroids (Not exceeding 10mg/day prednisone or its equivalent).
  • Have any active autoimmune disease or history of autoimmune disease.
  • Subjects with active tuberculosis.
  • Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.
  • Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT/QTc interval at baseline (male>450ms, female >480ms); (4) LVEF≤50%; (5) heart failure of NYHA class 2 or higher; (6) poorly controlled hypertension (BP≥150/95 mmHg, despite optimal medical treatment); (7) cardiomyopathy or severe arrhythmia and may have impact on the study based on investigator's judgement.
  • Subjects with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;
  • Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;
  • Known history of organ transplantation or ready to receive an organ transplantation;
  • Subjects who have undergone major surgery or traumatic injury within 4 weeks before randomization;
  • Those who have a history of alcohol dependence, psychotropic substance abuse and cannot abstain or have mental disorders.
  • Surgery for soft tissue sarcoma is planned during the study.
  • Subjects have participated in another investigational trial within 4 weeks before randomization.
  • Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenjin Huang contact

021-37690016

huangwenjin@shhryz.com

Xuemin Rao contact

raoxuemin@shhryz.com

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou

    Xing Zhang, MD,PHD, 02087343383, zhangxing@sysucc.org.cn

    Xing Zhang

    Recruiting

Other trials in China

About this study

Official title: A Phase II Study Evaluating the Safety and Efficacy of MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment in Patients With Advanced Soft Tissue Sarcoma

This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.

Read the detailed description

This is a multicenter, randomized, open-label study to evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with metastatic or recurrent unresectable advanced soft tissue sarcoma.

Being tested
MASCT-I, Doxorubicin, Ifosfamide
Medical subject headings
Leiomyosarcoma, Liposarcoma, Sarcoma, Synovial, Hemangiosarcoma, Histiocytoma, Malignant Fibrous, Sarcoma, Neurofibrosarcoma, Fibrosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MASCT-IBiological

    The final products of MASCT-I technology are dendritic cells (DC) and effector T cells.

  • DoxorubicinDrug

    Also called Doxorubicin hydrochloride for Injection

    Commercially approved for cancer treatment

  • IfosfamideDrug

    Also called Ifosfamide for Injection

    Commercially approved for cancer treatment

Study groups in NCT06277154
Study groupRoleWhat they receive
MASCT-I+ Doxorubicin+ IfosfamideExperimentalThe final products of MASCT-I technology are dendritic cells (DC) and effector T cells. DC cells injection will be given via subcutaneous injection, and T cells injection will be given via Intravenous (IV) infusion. Doxorubicin and Ifosfamide will be given per protocol.
Receives: Biological: MASCT-I; Drug: Doxorubicin; Drug: Ifosfamide
Doxorubicin+ IfosfamideActive comparatorDoxorubicin and Ifosfamide will be given per protocol.
Receives: Drug: Doxorubicin; Drug: Ifosfamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    The time from the date of randomization to the first occurrence of radiological progression or death, whichever comes first.

    Measured: 3 years

Secondary outcomes (7)

  1. Overall Survival (OS)

    The time from the date of randomization to the date of death from any cause.

    Measured: 3 years

  2. Objective Response Rate (ORR)

    The percentage of participants with complete response (CR) or partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population.

    Measured: 3 years

  3. Disease Control Rate (DCR)

    The percentage of participants with CR, PR, or stable disease (SD) relative to the total number of participants within the analysis population as determined by Investigators per RECIST v1.1.

    Measured: 3 years

  4. Duration of response (DoR)

    The time from first documentation of response of PR or better to first documentation of disease progression or death from any cause, whichever comes first.

    Measured: 3 years

  5. Adverse events and serious adverse events

    All adverse events and serious adverse events during the study

    Measured: 3 years

  6. Adverse events and serious adverse events related to MASCT-I

    All adverse events and serious adverse events related to MASCT-I during the study

    Measured: 3 years

  7. Rate and severity of clinically-significant abnormalities in laboratory testings

    Clinically-significant abnormalities in laboratory testings.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start21 Feb 2024
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06277154
Sponsor's protocol ID
MASCT-I-2004
Status last verified
Jun 2025
First submitted
2 Feb 2024
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MASCT-I, Doxorubicin and Ifosfamide in people with Leiomyosarcoma and Liposarcoma, run by HRYZ Biotech Co. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenjin Huang (021-37690016, huangwenjin@shhryz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06277154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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