jRCT2031260047招募中不适用
A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer
未提供0 个研究点目标入组 68 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with histologically confirmed unresectable adenocarcinoma of the colon or rectum.
- •Confirmed microsatellite stable (MSS) or proficient mismatch repair (pMMR) status.
- •Prior treatment with standard systemic chemotherapy and refractory or intolerant* to such therapies. Standard chemotherapy must include all of the following:
- •Fluoropyrimidine, irinotecan, and oxaliplatin (with or without anti-VEGF antibody therapy)
- •For patients with RAS and BRAF wild-type tumors: prior treatment with anti-EGFR monoclonal antibody (cetuximab or panitumumab)
- •For patients with BRAF V600E mutation: prior treatment with a BRAF inhibitor (encorafenib)
- •For patients who relapse during adjuvant chemotherapy or within 6 months after the last dose of postoperative adjuvant chemotherapy, that adjuvant therapy counts as prior systemic therapy.
- •Presence of measurable disease according to RECIST version 1.
- •Age >= 18 years at the time of informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Laboratory values within 14 days prior to enrollment meeting all of the following (tests performed on the same weekday 2 weeks before the enrollment date are acceptable):
- •(1) Absolute neutrophil count >= 1,500/mm3
- •(2) Hemoglobin >= 9.0 g/dL
- •(3) Platelet count >= 75,000mm3
- •(4) Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
- •(5) AST (GOT) =< 2.5 x ULN; =< 5 x ULN if liver metastases are present
- •(6) ALT (GPT) =< 2.5 x ULN; =< 5 x ULN if liver metastases are present
- •(7) Creatinine =< 1.5 mg/dL
- •(8) Proteinuria =< 1+ or < 1.0 g/24 h (urine protein-to-creatinine ratio < 1 may be used; if 24-hour urine is collected, the measured value takes precedence)
- •No blood transfusion within 7 days prior to enrollment (a transfusion given on the same weekday 1 week earlier is considered ineligible).
- •Women of childbearing potential must have a negative pregnancy test within 14 days prior to enrollment. Both male and female participants must agree to use appropriate contraception during the study and for 4 months after the last dose of study treatment. Female participants must also agree not to breastfeed during the study and for 4 months after the last dose. (Tests performed on the same weekday 2 weeks before the enrollment date are acceptable.)
- •Able to take oral medication.
- •Written informed consent obtained from the participant.
排除标准
- •Prior treatment with fruquintinib for metastatic colorectal cancer.
- •Prior treatment with any anti-CCR8 antibody, regardless of indication.
- •Receipt of chemotherapy, radiotherapy, immunotherapy, or any antitumor therapy, or investigational agents within 14 days prior to enrollment, or persistence of CTCAE Grade >= 2 toxicities from prior therapies (excluding alopecia, hyperpigmentation, and peripheral sensory neuropathy).
- •History of acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty, or stent placement within 6 months prior to enrollment.
- •History or current findings of congestive heart failure of NYHA Class III or higher.
- •Uncontrolled hypertension.
- •Known central nervous system metastases. (If CNS metastasis is clinically suspected, brain CT or MRI must be performed during screening.)
- •Active double primary malignancy (simultaneous or metachronous with disease-free interval < 2 years), except for carcinoma in situ or intramucosal carcinoma lesions considered curable by local therapy.
- •Serious comorbidities requiring inpatient treatment (e.g., paralytic ileus, bowel obstruction, pulmonary fibrosis, uncontrolled diabetes, heart failure, myocardial infarction, angina, renal failure, hepatic failure, psychiatric disorders, cerebrovascular disorders, or transfusion-requiring ulcers).
- •Active infections, including:
- •HBs antigen positive
- •Patients may be eligible if receiving nucleoside analog antiviral therapy and HBV-DNA < 20 IU/mL (1.3 log IU/mL).
- •HBs antibody positive or HBc antibody positive AND HBV-DNA positive
- •If HBV-DNA < 20 IU/mL, the patient may be eligible.
- •HCV antibody positive
- •Patients may be eligible if HCV-RNA is below the detection limit.
- •HIV positive
- •Patients may be eligible if HIV infection is ruled out by confirmatory testing.
- •Other active infections requiring treatment.
- •History of autoimmune disease or chronic/recurrent autoimmune disease (patients with type 1 diabetes, hypothyroidism manageable with hormone replacement, or localized skin diseases such as vitiligo, psoriasis, or alopecia not requiring systemic therapy are eligible).
- •Requirement for systemic corticosteroids or immunosuppressive agents, or receipt of such therapy within 2 weeks prior to enrollment (treatment given on the same weekday 2 weeks earlier renders the patient ineligible), except for temporary administration for testing, allergic reactions, or edema associated with radiotherapy.
- •Lack of willingness or inability to comply with study procedures.
- •Considered unsuitable for the study by the principal investigator or sub-investigator.
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