肿瘤细胞治疗研究
英文原题：NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer
NEOadjuvant Dendritic Cell Vaccination for Ovarian Cancer
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
这是一项 I/II 期注册临床试验，评估细胞治疗用于卵巢癌的疗效与安全性。当前状态：招募中。计划入组 10 例。试验地点：欧洲 · 奈梅亨（共 1 个中心）。登记号：NCT05773859。
仅女性 · ≥ 18 Years
纳入标准： • 年龄>18岁且经组织学确诊为原发性上皮性卵巢癌的女性。 • 不适合直接进行初次肿瘤减灭术，需要先接受新辅助化疗及间期减瘤手术。 • 高级别或低级别浆液性组织学类型。 • FIGO分期IIIb、IIIc、IVa或IVb；IVb期仅当膈上或腹股沟淋巴结≤1 cm时符合条件。 • 肿瘤广泛累及腹腔。 • WHO/ECOG体能状态0–1。 • 中性粒细胞>1.5×10⁹/L，血小板>100×10⁹/L，血红蛋白>5.6 mmol/L（9.0 g/dL），估算肾小球滤过率>45 mL/min/1.73 m²，AST/ALT<3倍ULN，血清胆红素<1.5倍ULN（Gilbert综合征者除外，仍可入组）。 • 预期能够充分接受随访。 • 已绝经、证实无生育能力，或有生育能力女性在研究治疗前28天内妊娠试验阴性，并在第1日治疗前再次确认。绝经定义为停止外源性激素治疗后闭经至少1年，或已手术绝育（双侧卵巢切除或子宫切除）。 • 已签署知情同意书。 排除标准： • 卵巢癌复发。 • 非高级别浆液性卵巢癌组织学类型，包括但不限于子宫内膜样癌、黏液性癌、透明细胞癌或癌肉瘤。 • 无法和/或不愿接受标准化疗及间期减瘤手术。 • FIGO I–IIb、IIIa期，或IVb期伴肝、脾或肺转移，或膈上/腹股沟淋巴结>1 cm。 • 有任何第二种恶性肿瘤史，但已充分治疗的基底细胞癌、5年以前的宫颈癌或10年以前的早期乳腺癌除外。 • 任何可能妨碍安全给予树突状细胞疫苗的严重临床状况。 • NYHA III/IV级心力衰竭。 • 任何未控制的合并症，例如影响参与研究的精神或社会状况。 • 无法接受肿瘤活检。 • 妊娠，或仍有生育可能但未采取充分避孕措施。 • 活动性乙肝、丙肝、HIV或梅毒感染。 • 其他严重活动性感染。 • 已知对贝类过敏。 • 自身免疫性疾病（白癜风除外，白癜风患者可入组）。 • 有器官异体移植史。 • 长期使用全身性免疫抑制药物（即泼尼松当量>10 mg）。
Inclusion criteria * Women over 18 years old with histologically confirmed primary epithelial ovarian cancer. * Not amenable by primary debulking surgery and in need of neoadjuvant chemotherapy and interval debulking * High-grade or low grade serous histology * FIGO stage IIIb, IIIc, IVa or IVb if only lymph nodes ≤ 1cm above the diaphragm or in the groins * Extensive abdominal spread of tumor * WHO/ECOG performance status 0-1 * Neutrophils \>1.5x 109/L, platelets \>100x 109/L, hemoglobin \>5,6 mmol/L (9.0 g/dl), estimated glomerular filtration rate \> 45 ml/min/1.73m2 , AST/ALT \<3 x ULN, serum bilirubin \<1.5 x ULN (exception: Gilbert's syndrome is permitted) * Expected adequacy of follow-up * Postmenopausal or evidence of non-childbearing status or for women of childbearing potential: negative urine or serum pregnancy test, within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as: * Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments; * or surgical sterilisation (bilateral oophorectomy or hysterectomy). * Informed consent Exclusion criteria * Recurrent ovarian cancer * Histologies other than high grade serous ovarian cancer such as, but not restricted to, endometrioid, mucinous, clear cell or carcinosarcoma * Unable and/or unwilling to undergo standard chemotherapy and interval debulking surgery * FIGO stage I-IIb, IIIa or IVb with liver, spleen or lung metastases or lymph nodes above the diaphragm or in the groins \> 1 cm * History of any second malignancy, with the exception of adequately treated basal cell carcinoma, cervical cancer \> 5 years ago or early stage breast cancer \>10 years ago. * Any serious clinical condition that may interfere with the safe administration of DC vaccinations * Heart failure (NYHA class III/IV) * Any uncontrolled co-morbidity, e.g. psychiatric or social conditions interfering which participation * Unable to undergo a tumor biopsy * Pregnancy or insufficient anti-conception if reproduction is still possible * Active infection of Hepatitis B, C, HIV and syphilis * Serious other active infections * Known allergy to shell fish * Auto immune disease (exception: vitiligo is permitted) * History of organ allografts * Chronic treatment with systemic immunosuppressive drugs (i.e. more than 10 mg prednisolone equivalent)
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Number of patients with an immunological response to XP-DC vaccination · Immunologically responding patients are defined as:
T cells isolated from vaccine challenged sites (DTH biopsies) that can be expanded and 1) express T cell receptors specific for the vaccine and 2) show effector functions measured by IFN-gamma secretion or cytolytic activity against tumor antigen expressing target cells.
Immunologically non-responding patients are defined as:
No T cells, or T cells isolated from DTH biopsies that cannot be expanded, or T cells that can be expanded but do not recognize tumor antigens, or can recognize tumor antigens but do not display T effector functions i.e. lysis of tumor cell targets or release of IFN-α. · At DTH skin test after the second vaccination (approximately study week 10)
次要终点：Safety as assessed by incidence of treatment-related adverse events；Feasibility of tumor lysate-loaded XP-DC vaccinations in patients with advanced EOC；Recurrence free survival (RFS) after 12 months；Number of patients with complete pathological response
该组患者在接受标准治疗的基础上，另接受XP-DC疫苗接种。
以上邮箱 / 电话是登记库里的申办方联系方式，通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。
这是一项单臂、单中心、探索性I/II期临床试验，旨在进一步了解自体肿瘤裂解物负载XP-DC（cDC1）疫苗用于卵巢癌患者的免疫学疗效、安全性和可行性。
This goal of this single arm, single center, exploratory phase I/II clinical trial is to learn more about the immunological efficacy, safety and feasibility of an autologous tumor lysate-loaded autologous XP-DC (cDC1)-based vaccine in patients with ovarian cancer.
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