OncoMatch/Clinical Trials/NCT06277154
MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma
Is NCT06277154 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including MASCT-I and Doxorubicin for leiomyosarcoma.
Treatment: MASCT-I · Doxorubicin · Ifosfamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Rhabdomyosarcoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: disease progressed after 6 months of the end of neoadjuvant or adjuvant therapy
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.
Cannot have received: targeted therapy
Exception: disease progressed after 6 months of the end of neoadjuvant or adjuvant therapy
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.
Cannot have received: targeted therapy
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.
Cannot have received: radiotherapy
Exception: radiotherapy to non-target lesions or disease progressed after radiotherapy could be included
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.
Cannot have received: other antineoplastic drugs (anlotinib, gemcitabine)
other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization
Cannot have received: Chinese medicine or proprietary Chinese medicine for anti-tumor treatment
have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization
Cannot have received: anthracycline or anthraquinone
Exception: cumulative dose does not exceed equivalent 200mg/m2 doxorubicin
Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg/m2 doxorubicin
Cannot have received: MASCT
Previous treatment with MASCT
Cannot have received: cellular immunotherapy
have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year
Cannot have received: anti-PD-1 therapy
have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year
Cannot have received: anti-PD-L1 therapy
have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year
Lab requirements
Blood counts
hemoglobin ≥90g/L; leukocyte≥3.5x10^9/L; ANC>1.5x10^9/L; platelet≥100x10^9/L
Kidney function
serum urea nitrogen or urea and creatinine≤2.5 ULN
Liver function
ALT, AST≤2.5 ULN (≤5 ULN for liver metastases); ALP≤2.5 ULN; serum total bilirubin≤1.5 ULN (Gilbert's syndrome allowed with investigator's agreement)
Cardiac function
PT, APTT, INR≤1.5 ULN (without anticoagulation treatment)
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);
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify