NCT06345287招募中2 期
Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related Head and Neck Squamous Cell Carcinoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2024年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.
详细描述
Induction chemotherapy combined with immunotherapy has shown promising efficacy in locally advanced head and neck cancers. However, the appropriate dose and range of the following radical radiotherapy treatment remains unknown. Eligibility patients were assigned to three arms depending on the degree of clinical remission: clinical complete response (radiotherapy 60Gy + concurrent chemotherapy + immunotherapy maintenance), deep partial response (radiotherapy 66Gy + concurrent chemotherapy + immunotherapy maintenance, non-deep partial response (radiotherapy 70Gy + concurrent chemotherapy + immunotherapy maintenance). Progression-free survival, overall survival, and treatment-related toxicity would be calculated to evaluate the efficacy of treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Head and neck squamous cell carcinoma patients who undergo 2-4 cycles of induction chemotherapy and immunotherapy and plan to undergo radical radiotherapy treatment ( after MDT evaluation and communication with the patient, surgery is not recommended to preserve organ function, or the patient refuses surgery );
- •Age range from 18 to 75 years old;
- •Squamous cell carcinoma of the head and neck confirmed by pathological tissue biopsy;
- •Clinical staging is T1-2N2-3M0, T3-4N0-3M0 (AJCC 8th edition);
- •HPV or P16 (-);
- •ECOG score 0-1 points;
- •No contraindications to immunotherapy and radiotherapy;
- •The functional level of the main organs meets the following standards:1) The blood routine examination standards need to meet: WBC ≥ 3.0 × 109/L, ANC ≥ 2.0 × 109/L, PLT ≥ 100 × 109/L, HGB ≥ 90g/L (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulating factors correction);2) Biochemical examination must meet the following standards: TBIL ≤ 2.0 × ULN, ALT, AST ≤ 2.5 × ULN, BUN and CRE ≤ 1.5 × ULN, or endogenous creatinine clearance rate ≥ 60ml/min (Cockcroft Gout formula);3) Good coagulation function: defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; If the subject is receiving anticoagulant treatment, as long as the PT is within the intended range of use of the anticoagulant drug;4) The myocardial enzyme spectrum is within the normal range;
- •Women of childbearing age must have taken reliable contraceptive measures, or have undergone pregnancy tests (serum or urine) within 7 days before enrollment, and the results are negative. They must be willing to use effective methods of contraception during the treatment period and within 2 months thereafter. For male participants whose partners are women of childbearing age, effective methods of contraception should be used during and within 2 months after treatment;
- •Voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.
排除标准
- •Previous or concurrent incurable malignant tumors in other parts, except cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma and superficial bladder cancer;
- •Suffering from any active autoimmune disease or having a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after normal hormone replacement therapy); Asthma patients who suffer from vitiligo or have completely relieved childhood asthma and do not require any intervention in adulthood can be included, while asthma patients who require medical intervention with bronchodilators cannot be included;
- •Suffering from uncontrolled cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥ 470 ms); According to NYHA standards, patients with grade III-IV cardiac dysfunction or those with left ventricular ejection fraction (LVEF)<50% indicated by echocardiography; Have experienced myocardial infarction within one year;
- •Active infection or unexplained fever exceeding 38.5 ℃ during screening or before first administration (according to the researcher's judgment, subjects with fever caused by tumors can be included in the study);
- •People with congenital or acquired immune deficiency (such as HIV infected people), active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCR-RNA is higher than the detection limit of the analytical method);
- •Previously received other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1;
- •Known to be allergic to cisplatin, macromolecular protein preparations, or any anti PD-1 antibody component;
- •If the subject undergoes major surgery without tumor treatment, the toxic reactions and/or complications caused by the surgical intervention must be fully recovered before starting treatment;
- •Pregnant or lactating women;
- •In the investigator's judgment, the subjects had other factors that might have led to their forced discontinuation of the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory test values, or family or social factors that might have affected the safety of the subjects or the circumstances of the trial data collection.
结局指标
主要结局
Progression-free survival
时间窗: 2 years
defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 2 years of treatment
次要结局
- Local-Regional failure survival(2 years)
- Deep partial response(2 years)
- Toxicity Adverse events(2 years)
- Overall survival(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Adaptive Radiotherapy in Patients With Gynecological TumorsGynecological TumorAdaptive RadiotherapyRadiationCurative TreatmentOptimizationAdaptive Radiation TherapyImage Guided RadiotherapyCervical CarcinomaNCT06230549University Hospital, Essen30
已完成
不适用
Adaptative Radiotherapy for Locally Advanced Cervical CancerUterine Cervical CancerNCT02937948Center Eugene Marquis85
已完成
不适用
Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung CancerNon Small Cell Lung Cancer MetastaticNCT03035890West Virginia University35
Unknown
1 期
Pilot Project of Adaptive Thoracic Radiotherapy for Small Cell Lung CancerSmall Cell Lung CancerNCT01426841AHS Cancer Control Alberta10
招募中
不适用
Adaptive Radiation in Anal CancerAnal Squamous Cell CarcinomaNCT05838391Columbia University20