JPRN-jRCTs071200101招募中2 期
Chemotherapy combined durvalumab with concurrent or sequential TRT in patients with ED-SCLC: an open-label, phase 2 study - SPIRAL-SMALL Study
Takayama Koichi0 个研究点目标入组 60 人开始时间: 2021年2月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Patients providing the written informed consent.
- •2)Patient with at least 20 years of age (at enrolment date).
- •3)ECOG performance status of 0 or 1
- •4)Patients with small cell lung cancer confirmed histologically or cytologically,and diagnosed as extensive-disease depending on the degree of progression.
- •5)Patients without symptomatic brain metastases. For patients with brain metastases, use of steroids and anticonvulsants for at least 1 month prior to enrolment should be stable.
- •6)Patients with no prior treatment history for extensive-disease small cell lung cancer.
- •7)Patients with at least one measurable lesion as defined in RECIST criteria version 1.1.
- •8) Patients with lung lesions suitable for irradiation.
- •9) Body weight >30 kg
- •10) Patients with life expectancy of at least 12 weeks at the time of enrolment.
- •11)The functions of major organs such as bone marrow, liver, and kidney are maintained and the following criteria are met within 2 weeks before enrolment (test on the same day of the week 2 weeks before enrolment is eligible)
- •Hemoglobin >= 9.0 g/dL
- •Absolute neutrophil count (ANC) >= 1.5 x 10^3 / microL
- •Platelet count >= 100 x 10^3 / microL
- •Serum bilirubin <=1.5 x institutional upper limit of normal (ULN).(however, <= 3 x ULN with Gilbert's syndrome)
- •AST (SGOT)/ALT (SGPT) <= 2.5 x ULN (however,<=5 x ULN with liver metastases)
- •12) In the case of women, patients who can be confirmed to be postmenopausal.
- •Moreover, in the case of premenopausal women, effective contraceptive methods are being implemented and pregnancy is negative or 28 days or more after childbirth and
- •not breastfeeding.
排除标准
- •1) Patients with known allergies, hypersensitivity, or medical contraindications to durvalumab, platinum (carboplatin or cisplatin), etoposide, or their pharmaceutical additives.
- •2) Patients receiving combination chemotherapy, investigational new drugs, biologics, or hormone therapy for the treatment of cancer.
- •3) Patients with a medical history of thoracic radiation therapy.
- •4) Patients with major surgery within 28 days prior to enrolment.
- •5) Patients with a medical history of allogeneic organ transplantation.
- •6) Patients requiring systemic treatment (systemic steroids or immunosuppressants) for autoimmune paraneoplastic syndrome (PNS), or patients with clinical symptoms suggesting worsening of PNS.
- •7) Patients with autoimmune disease or inflammatory disease, diverticulitis, systemic lupus erythematosus, sarcoidosis syndrome or Wegener's syndrome confirmed now or in the past.
- •8) Patients with infectious diseases requiring systemic treatment (administration of antibacterial drugs and antifungal drugs)
- •9) Patients with psychosis or psychiatric symptoms that may interfere with the
- •implementation of protocol treatment, and that the investigator judges as difficult to participate in the study.
- •10) Patients with clinically significant complications.
- •Serious or uncontrollable systemic disease (active infections including uncontrollable hypertension, heart disease, severe arrhythmias requiring medication, persistent watery diarrhoea, active bleeding)
- •11) Patients with obvious active interstitial lung disease.
- •12) Patients with uncontrollable diabetes mellitus.
- •13) Patients with active double cancer (simultaneous double cancer and metachronous double cancer with a disease-free period of 5 years or less).
- •14) Patients with anamnesis of meningeal dissemination.
- •15) Patients with anamnesis of active primary immunodeficiency.
- •16) Patients with active infections such as tuberculosis and hepatitis B.
- •17) Patients with a history of immunosuppressive drug use at present or within 14 days before enrolment.
- •18) Patients with administration of live attenuated vaccine within 30 days before enrolment.
- •19) Pregnant or lactating women, or fertile men or women who are unwilling to adopt effective contraception from screening to 90 days after the final dose of durvalumab.
- •20) Any other patients who are regarded as unsuitable for this study by the investigators.
研究者
相似试验
招募中
2 期
Neo-adjuvant Chemo and immunotherapy with durvalumab (MEDI4736) and tremelimumab (MEDI1123) In The pre-operAtive Treatment of locally advanced cholangIOcarciNoma: an exploratory and translational study.2024-518656-23-00IRCCS Istituto Nazionale Tumori Fondazione Pascale38
进行中（未招募）
1 期
Treatment to modulate the activity of the immune system in combination with chemotherapy treatment in patients with operable urothelial cancerEUCTR2017-003565-10-DESwiss Group for Clinical Cancer Research61
进行中（未招募）
1 期
Immunotherapy in combination with chemotherapy in small-cell lung cancer.EUCTR2017-004784-12-GRHellenic Cooperative Oncology Group (HeCOG)55
进行中（未招募）
1 期
Study on the combination of two immunotherapeutic agents as pre-surgical therapy or definitive treatment in patients with resectable gastric or gastroesophageal junction cancer with microsatellite instability.The disease under clinical investigation is represented by resectable gastric or gastroesophageal junction (Siewert II-III) adenocarcinoma staged as cT = 2, any cN, or any cT, cN1-3 (TNM classification 8th edition), without distant metastases (cM0).The study requires central confirmation of tumor molecular status of microsatellite instability and dMMR by both immunohistochemistry and multiplex polymerase chain reaction, and EBV-negative status by silver-in situ hybridization.MedDRA version: 20.0Level: LLTClassification code 10073379Term: Tubular adenocarcinoma gastricSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10073378Term: Signet-ring cell adenocarcinoma gastricSystem Organ Class: 100000004864EUCTR2020-003440-92-ITG.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST31
招募中
不适用
Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly and/or Frail Stage III Non-small-cell Lung CancerNon-small Cell Lung Cancer Stage IIINCT05557552Ruijin Hospital56