NCT06055166尚未招募2 期
A Prospective, Multi-cohort, Single-center Phase II Clinical Study of Chemoradiotherapy Sequential Fluzoparib in Pan-solid Tumors
Chongqing University Cancer Hospital0 个研究点目标入组 120 人开始时间: 2023年11月1日最近更新:
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
- 发起方
- 入组人数
- 120
- 主要终点
- pCR
研究概览
简要总结
This study is a prospective, multi-cohort, single-centre, phase II clinical trial designed to initially explore the efficacy and safety of sequential fluzoparib with chemoradiotherapy in pan-solid tumours. The study is designed for patients with untreated surgically resectable rectal cancer and untreated locally advanced unresectable non-small cell lung cancer, oesophageal squamous cancer, and cervical cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Subjects must meet all of the following criteria to be enrolled in this study:
- •subjects voluntarily enrolled in this study, signed informed consent, good compliance, and co-operated with follow-up visits;
- •age 18-75 years (calculated on the date of signing the informed consent);
- •histologically or cytologically confirmed solid tumours as follows: Cohort A: patients with resectable locally advanced rectal adenocarcinoma not previously treated for rectal cancer (clinical stage T3-4 or N+ as assessed by MRI, according to AJCC 8th edition staging), with the lower edge of the tumour ≤ 10 cm away from the anal verge, with R0 resection predicted and planned for surgery after neoadjuvant therapy, and with no contraindications to surgery; Cohort B: patients with locally advanced, unresectable NSCLC with histologically or cytologically confirmed diagnosis who have not previously received treatment for lung cancer (IIIA, IIIB, IIIC, according to the International Manual of Thoracic Oncology Lung Cancer Staging Studies 8th edition staging); Cohort C: patients with locally advanced, unresectable or contraindicated for or refusing surgery for squamous oesophageal cancer with histological or cytological confirmation who had not received previous treatment for oesophageal cancer (clinical staging T1b-4bN0M0/T1-4bN+M0, according to AJCC 8th edition staging); Cohort D: Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix that has not received prior treatment for cervical cancer (excluding surgical pathological staging) and that has been confirmed by pathohistology. Clinical staging or imaging staging or surgical pathological staging of locally advanced cervical cancer (2018 FIGO staging of IB3, Stage IIA2-IVA patients);
- •NSCLC without sensitive EGFR, ALK or ROS1 gene mutations confirmed by histological or cytological specimens;
- •ECOG PS score: 0 to 1;
- •subjects with normal swallowing function;
- •normal major organ function, including:
- •a) Routine blood tests (no transfusion of blood or blood products, no correction with G-CSF and other haematopoietic stimulating factors within 14 days prior to the first treatment): i. Neutrophil count ≥ 1.5 × 109/L ii. Platelet count ≥ 100×109/L iii. Haemoglobin ≥ 90 g/L. b) Blood biochemistry: i. Total bilirubin ≤ 1.5×ULN ii. ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN. iii. iii. serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min c) Coagulation function: i. International Normalised Ratio (INR) ≤ 1.5 x ULN ii. Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN
- •Female subjects of childbearing potential are required to have a negative serum pregnancy test within 72 hours prior to the first dose and are not breastfeeding and are using effective contraception (e.g., IUD, birth control pills, or condoms) for the duration of the trial, and for 6 months after the last administration of fluzoparib/chemotherapy, or 2 months after the last administration of karelizumab, whichever is longer; for male subjects whose partner is a female of childbearing potential, the results of the serum pregnancy test must be negative and they must be not breastfeeding. male subjects whose partner is a female of childbearing potential should be surgically sterilised or agree to use effective contraception for the duration of the trial and for 6 months after the last administration of fluzoparib/chemotherapy or 2 months after the last administration of carrelizumab, whichever is longer, and sperm donation is not permitted during the study.
- •patients judged by the investigator to be acceptable for the study intervention programme.
排除标准
- •Subjects with any of the following traits or conditions will not be allowed to enter this study:
- •patients with a previous history of perforation, fistula, bleeding or airway stenosis;
- •a history of allergy or risk of allergy to the study intervention protocol;
- •subjects may receive other systemic anti-tumour therapy during the study period;
- •the presence of abnormal gastrointestinal function which, in the judgement of the investigator, may interfere with drug absorption
- •the presence of uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
- •subjects with congenital or acquired immune deficiency (e.g., HIV-infected), or active hepatitis (Hepatitis B reference: HBsAg positive, HBV DNA ≥2000 IU/ml; Hepatitis C reference: HCV antibody positive, HCV viral copy number > upper limit of normal);
- •have clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA class 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia that requires treatment or intervention (5) those with a QTc > 470 ms;
- •those with abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds), bleeding tendency or who are receiving thrombolytic or anticoagulant therapy are permitted to receive low-dose low molecular heparin or oral aspirin for prophylactic anticoagulation during the trial;
- •have had a serious infection (CTCAE > grade 2) within 4 weeks prior to first use of study drug, such as severe pneumonia requiring hospitalisation, bacteraemia, or infectious co-morbidities; except for prophylactic antibiotic use in those who have baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection within 14 days prior to the first use of study drug, or who require treatment with oral or intravenous antibiotics ;
- •patients with any active autoimmune disease or a history of autoimmune disease with potential for relapse [including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (patients who can be controlled by hormone replacement therapy alone may be enrolled)] are not eligible for enrollment into Cohort B; patients with skin diseases that do not require systemic therapy Patients with skin diseases that do not require systemic treatment, such as leukoplakia, psoriasis, alopecia areata, patients with type I diabetes mellitus controlled by insulin therapy or patients with a history of asthma that has completely resolved in childhood and does not require any intervention can be enrolled; patients with asthma requiring bronchodilator intervention cannot be enrolled in Cohort B;
- •women who are pregnant or breastfeeding;
- •the presence of other factors that, in the judgement of the investigator, could lead to forced termination of the study midway, such as the presence of other serious illnesses (including psychiatric illnesses) that require comorbid treatment, alcoholism, drug abuse, family or social factors that may affect the safety of or compliance with the subject;
研究组 & 干预措施
untreated surgically resectable rectal cancer
Experimental
干预措施: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) (Drug)
untreated locally advanced unresectable non-small cell lung cancer
Experimental
干预措施: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) (Drug)
untreated locally advanced unresectable esophageal squamous cell carcinoma
Experimental
干预措施: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) (Drug)
untreated locally advanced unresectable cervical carcinoma
Experimental
干预措施: Fluzoparib monotherapy or Fluzoparib with Camrelizumab(Only non-small cell lung cancer arm) ,or Fluzoparib combined with capecitabine (only rectal cancer arm)) (Drug)
结局指标
主要结局
pCR
时间窗: within 14 working days after operation
Pathological Complete Response
PFS rate
时间窗: from initially chemoradiotherapy follow up 12 months
12-month Progression-Free Survival Rate
次要结局
- R0 resection rate(within 14 working days after operation)
- PFS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- MPR(within 14 working days after operation)
- OS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- ORR(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- AEs(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
研究者
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