EUCTR2019-001471-36-GB进行中（未招募）1 期
Priming the Tumour MicroEnvironment for Effective Treatment with Immunotherapy in Locally Advanced Rectal Cancer: A Phase II trial of Durvulamab in Combination with Extended Neoadjuvant Regimens in Rectal Cancer - PRIME-RT
HS Greater Glasgow and Clyde0 个研究点目标入组 54 人开始时间: 2020年8月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Be willing and able to provide written informed consent for the trial.
- •2.Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures including willingness to provide repeated biopsy samples of tumour via flexible sigmoidoscopy.
- •3.Age 16 or over on the day of signing informed consent.
- •4.Histologically confirmed non-metastatic, locally advanced rectal adenocarcinoma deemed appropriate for radical treatment.
- •5.Non-metastatic disease confirmed with CT of chest/abdomen and pelvis. Note: Suspicious extramesorectal lymph nodes identified on initial staging investigations are not considered an exclusion criteria if the local MDT deem these resectable at and would treat patients with curative intent.
- •6.The rectal tumour must have at least one of the following high risk criteria on MRI scan:
- •cT3b+ OR
- •EMVI positive, OR
- •Primary tumour or morphologically malignant lymph node at 1mm or less from the mesorectal fascia or beyond the mesorectal fasica OR
- •Low rectal tumour and the consensus of the multi-disciplinary meeting is that abdomino-perineal excision would be required for sufficient surgical management.
- •7.ECOG performance status 0-1 (see Appendix 2)
- •8.No contra-indication to treatment with pelvic radiotherapy. For example, no pre-existing condition which would deter radiotherapy, e.g.Table of, fistulas, severe ulcerative colitis (particularly subjects currently taking sulphasalazine), Crohn’s disease, prior adhesions.
- •9.Primary disease which can be encompassed within a radical radiotherapy treatment volume.
- •10.Adequate haematological and biochemical function as indicated below. These measurements should be performed within 7 days prior to randomisation:
- •- Absolute neutrophil count > 1.5 x 10-9/L.
- •- Platelets =100 x109/l.
- •- Haemoglobin =90 g/l. Transfusion is acceptable if necessary to increase haemoglobin levels.
- •- Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) =1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
- •- Activated Partial Thromboplastin Time (aPTT) =1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
- •- Renal Creatinine OR Measured or calculated a creatinine clearance* (GFR can also be used in place of creatinine or CrCl) =1.5 X upper limit of normal (ULN) OR =660 mL/min for subject with creatinine levels > 1.5 X institutional ULN.
- •*Creatinine clearance should be calculated per institutional standard.
- •- Bilirubin <1.5 x upper limit of normal (ULN) except for unconjugated hyperbilirubinemia in patients who have Gilbert’s syndrome. In this case direct bilirubin must be = ULN for subjects with total bilirubin levels > 1.5 ULN.
- •- AST and ALT = 2.5 X ULN.
- •- Albumin = 2.5 g/dL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Patients with DPD deficiency (any degree).
- •2.Unable to have MRI assessment
- •3.Patient weight less than or equal to 30kg.
- •4.Previous pelvic radiotherapy
- •5.Metastatic disease defined by CT (includes resectable metastases).
- •6.Previous treatment with immunotherapy including but not limited to anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agents, interferon or anti-IL2 for the treatment of malignancy.
- •7.Previous treatment with chemotherapy for the treatment of current malignancy or treatment with chemotherapy within the last 5 years for a separate malignancy (unless that malignancy was treated squamous/basal cell skin cancer, treated early stage cervical cancer or treated/biochemically stable, organ confined prostate cancer).
- •8.History of a separate malignancy in the last 5 years (other than treated squamous/basal cell skin cancer, treated early stage cervical cancer or treated/biochemically stable, organ confined prostate cancer).
- •9.Pregnant or lactating females or males unwilling to use a highly effective method of contraception. Women of childbearing potential, and men with female partners of childbearing potential, must agree to use adequate contraceptive measures for the duration of the study and for 6 months after the completion of study treatment.
- •10. Major surgery within 28 days prior to trial entry
- •11. Prolongation of corrected QT (QTc) interval to >470 msec when electrolyte balance is normal.
- •12. Recent occurrence (within 3-6 months) of a major thromboembolic event, such as pulmonary embolism or proximal deep vein thrombosis, unless stable on (2 weeks) therapeutic anticoagulation (aspirin <325 mg daily or low-molecular-weight heparin [LMWH]). Subjects with a history of clinically non-significant thromboembolic events, not requiring anticoagulation, are allowed on study.
- •13.Active inflammatory bowel disease affecting the colon and rectum based on previous endoscopy and defined by ongoing drug treatment.
- •14. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •15. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- •16. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisolone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial drug.
- •17. Has a history of (non-infectious) interstitial pneumonia or pneumonitis that required steroids or current pneumonitis.
- •18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- •19.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •20.Has received a live vaccine within 30 days prior to the first dose of trial drug.
- •21.Any patients receiving treatment with brivudine, sorivudine and analogues or patients who have not s
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