NCT07842276尚未招募2 期
Phase II Clinical Study of Utidelone Capsules (UTD2) Combined With Doxorubicin for Advanced Soft Tissue Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Progression-Free Survival, PFS
研究概览
简要总结
This trial is an open, multicenter, phase II clinical trial evaluating the efficacy and safety of uterostatin capsules (UTD2) combined with doxorubicin and tislelizumab in the treatment of advanced soft tissue sarcoma. A total of 49 participants are planned to be enrolled. Participants who meet the inclusion criteria will receive UTD2 + doxorubicin + tislelizumab. Doxorubicin will be administered for a maximum of 6 cycles. Participants who have no tumor response or a non-progressive disease (CR, PR, SD) after discontinuation of doxorubicin will receive UTD2 + tislelizumab for maintenance treatment. Maintenance treatment will last for a maximum of 2 years, but tislelizumab monotherapy maintenance treatment will last for a maximum of 1 year.
详细描述
The participants with advanced soft tissue sarcoma in the study received treatment with UTD2 (60mg/m2/d, days 1-5, taken orally on an empty stomach) + doxorubicin (75mg/m2/d, day 1, intravenous infusion) + tislelizumab (200mg, day 1, intravenous infusion) every 3 weeks as a treatment cycle. Doxorubicin could be used for a maximum of 6 cycles. Then they entered the maintenance stage of UTD2 + tislelizumab. The length of the treatment cycle depends on the sensitivity and tolerance of the participants to the drugs. The participants continued the treatment until disease progression (evaluated by the investigator according to RECIST v1.1), occurrence of intolerable toxicity, withdrawal of informed consent by the participants, loss to follow-up, study termination, death, the investigator's judgment that the medication must be discontinued or the maintenance treatment must be completed (whichever occurred first). Safety evaluations were also conducted, and adverse events were graded according to NCI CTCAE 5.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand the purpose, content, process of the trial and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form;
- •Age of 18-70 years old (including 18 and 70 years old) at the time of informed consent (ICF) signing, regardless of gender.
- •Histopathologically /cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcoma (classified per the 5th WHO classification, including leiomyosarcoma, liposarcoma, angiosarcoma, epithelioid sarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma, malignant peripheral nerve sheath tumor, myxofibrosarcoma, pleomorphic rhabdomyosarcoma, etc.).
- •No prior systemic anti-tumor therapy for advanced soft tissue sarcoma. For participants with prior neoadjuvant or adjuvant therapy, disease progression must occur >6 months after the last treatment.
- •At least one measurable lesion according to RECIST v1.1 definition.
- •ECOG performance status of 0 or 1, with an expected survival of more than 12 weeks.
- •Within 1 week before enrollment, the participant's blood routine examination was basically normal, and within 2 weeks before enrollment, the participant did not receive recombinant human granulocyte colony-stimulating factor (rhG-CSF) or blood products/erythropoietin (EPO).
- •Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
- •Platelet count (PLT) ≥100×10⁹/L;
- •Hemoglobin ≥9.0 g/dL.
- •Blood biochemical examination was basically normal within 1 week before enrollment.
- •Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN);
- •Alanine aminotransferase (ALT) ≤3 × ULN (≤5 × ULN for participants with liver metastases);
- •Aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN for participants with liver metastases).
- •Left ventricular ejection fraction (LVEF) of echocardiography is ≥ 55%.
- •Eligible participants of reproductive potential (male and female) must agree to use reliable contraception (hormonal, barrier methods or abstinence) together with their partner during the study period and for at least 6 months after the last study drug administration. Females of childbearing potential must have a negative serum or urine pregnancy test prior to enrollment.
排除标准
- •Within the 3 years prior to enrollment, the participant had suffered from other malignant tumors, excluding cured cases of skin basal cell carcinoma or skin squamous cell carcinoma, cervical carcinoma in situ, or thyroid papillary carcinoma.
- •Tumor subtypes including gastrointestinal stromal tumor, non-pleomorphic rhabdomyosarcoma, undifferentiated small round cell sarcoma, desmoplastic small round cell tumor, alveolar soft part sarcoma, clear cell sarcoma, etc.
- •The participant had previously received anthracycline-based treatment, or had contraindications to doxorubicin treatment (the relevant contraindications can be found in the doxorubicin instructions), or was assessed by the investigator as not suitable for doxorubicin treatment.
- •Participants with previous use of oltiderone.
- •Within 2 weeks prior to enrollment, the participant had received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications; within 2 weeks prior to enrollment, the participant had received local radiotherapy.
- •Within 4 weeks prior to enrollment, the participant had undergone major surgical treatment, significant traumatic injury, or planned to undergo major surgery during the study period, or had long-standing unhealed wounds or fractures.
- •Planned to receive surgical treatment, radiotherapy, or other systemic anti-tumor therapy for soft tissue sarcoma during the study.
- •CTCAE 5.0 grade > 1 for symptomatic peripheral neuropathy.
- •The adverse effects of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicities without safety risk judged by investigators, such as alopecia).
- •Tumor with active bleeding.
- •Participants with symptomatic/uncontrolled central nervous system metastases or leptomeningeal metastases, including but not limited to participants with confirmed progressive brain metastases on imaging 2 months after radiotherapy or other local therapies, or participants deemed ineligible for enrollment by the investigator.
- •Uncontrolled bone metastases, defined as participants with existing or imminent fracture risk, requiring surgery or local radiotherapy in the near term, or with other critical conditions as assessed by the investigator.
- •Participants with uncontrolled pleural effusion or ascites requiring repeated drainage (once monthly or more frequently), and moderate or greater pericardial effusion.
- •Participants with gastrointestinal diseases such as esophageal obstruction, pyloric obstruction, intestinal obstruction, or status post gastrointestinal resection, or other factors causing dysphagia that affect oral drug administration and absorption.
- •History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- •Severe cardiac rhythm or conduction abnormalities, such as clinically significant ventricular arrhythmias requiring intervention, second- or third-degree atrioventricular block; history of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting; average QTcF ≥450 ms (male)/QTcF ≥470 ms (female) from three 12-lead ECGs at rest [see formula in Appendix 3]; New York Heart Association (NYHA) Class II-IV heart failure;
- •Stroke or other Grade ≥3 cerebrovascular events within 3 months prior to enrollment; or symptomatic cerebral infarction;
- •Clinically uncontrolled hypertension;
- •Past or current other high-risk cardiovascular and cerebrovascular diseases deemed to interfere with this trial by the investigator.
- •Participants with active infection requiring current systemic anti-infective therapy.
- •Participants with psychiatric disorders or poor compliance.
- •Pregnancy (positive pregnancy test) or lactation.
- •Within the previous 4 weeks prior to enrollment, participants had participated in another interventional clinical study or received treatment from other studies (participants who have completed other study treatments and are currently in the follow-up period are allowed to enroll in this study).
- •Participants with other severe systemic diseases or abnormal laboratory findings that render them unsuitable for participation in this study as judged by the investigator.
研究组 & 干预措施
UTD2 + tislelizumab + doxorubicin
Experimental
干预措施: UTD2 + tislelizumab + doxorubicin (Drug)
结局指标
主要结局
Progression-Free Survival, PFS
时间窗: up to 18 months
time from the first dose to disease progression or any-cause death
次要结局
- Objective Response Rate （ORR）according to the RECIST 1.1(up to 18 months)
- Disease Control Rate （DCR）according to the RECIST 1.1(up to 18 months)
- Duration of response (DoR) according to the RECIST 1.1(up to 18 months)
- Treatment-related Adverse Event-TRAE(Until 28 days after the last dose of treatment)
研究者
研究点 (1)
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