A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Liang'jun Zhu
- 전화번호: 13505199123
- 이메일: zhulj98@foxmail.com
연구 장소
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Jiangsu
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Changzhou, Jiangsu, 중국, 213000
- The First People's Hospital of Changzhou
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Changzhou, Jiangsu, 중국, 213000
- Changzhou Tumor Hospital (Changzhou Fourth People's Hospital)
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연락하다:
- Yong Liu
- 전화번호: 13921033137
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Changzhou, Jiangsu, 중국, 213000
- Liyang People's Hospital
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연락하다:
- Liqun Zhu
- 전화번호: 13626255262
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Huai'an, Jiangsu, 중국, 223000
- Huaian First People's Hospital
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연락하다:
- Xiaomin Zhong
- 전화번호: 13912074971
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Lianyungang, Jiangsu, 중국, 222000
- The first people's hospital of Lianyungang
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Nanjing, Jiangsu, 중국, 210000
- First Affiliated Hospital of Nanjing Medical Unviersity
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연락하다:
- Jing Sun
- 전화번호: 13914704178
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Nanjing, Jiangsu, 중국, 210000
- Jiangsu Cancer Institute & Hospital
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연락하다:
- Liang'jun Zhu
- 전화번호: 13505199123
- 이메일: zhulj98@foxmail.com
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Nantong, Jiangsu, 중국, 226000
- Nantong University Cancer Hospital
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연락하다:
- Lei Yang
- 전화번호: 158 5139 8092
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Nantong, Jiangsu, 중국, 226000
- The First People's Hospital of Nantong
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연락하다:
- Liang zhang
- 전화번호: 137 0629 5558
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Suzhou, Jiangsu, 중국, 215000
- Suzhou Municipal Hospital
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연락하다:
- jianming Shi
- 전화번호: 138 1525 9001
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Suzhou, Jiangsu, 중국, 215000
- Changshu No.2 People's Hospital
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연락하다:
- Yulan Gu
- 전화번호: 13812971602
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Wuxi, Jiangsu, 중국, 214400
- Jiangyin People's Hospital
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연락하다:
- Qiong Wang
- 전화번호: 136 0616 8002
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Wuxi, Jiangsu, 중국, 214000
- Wuxi Huishan District People's Hospital
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연락하다:
- Ning Ding
- 전화번호: 177 0617 8690
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Xuzhou, Jiangsu, 중국, 221000
- Xuzhou First People's Hospital
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연락하다:
- Taifeng Liu
- 전화번호: 13685183529
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Yangzhou, Jiangsu, 중국, 225000
- Yangzhou University Affiliated Jiangdu People's Hospital
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연락하다:
- Min Liao
- 전화번호: 15952578622
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Yangzhou, Jiangsu, 중국, 225000
- Yizheng People's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 18 to 75 years (inclusive), male or female.
- Diagnosis of advanced unresectable or metastatic colorectal cancer.
- Confirmed RAS/BRAF mutation by testing.
- No prior systemic therapy for unresectable or metastatic colorectal cancer. (Prior adjuvant or neoadjuvant chemotherapy with one regimen is allowed if recurrence occurred ≥6 months after completion of chemotherapy.)
- ECOG 0 - 1.
Adequate major organ and bone marrow function (without any blood component or cell growth factor support within 14 days before enrollment):
- Hematology: absolute neutrophil count ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, hemoglobin ≥90 g/L.
- International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- Liver function: total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN (≤5 × ULN in patients with liver metastases).
- Renal function: serum creatinine ≤1.5 × ULN, and creatinine clearance (CCr) ≥50 mL/min.
- Female patients of childbearing potential must have a negative serum pregnancy test within 14 days before treatment. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the study and for at least 6 months after the last dose
Exclusion Criteria:
- - History of hypersensitivity to any anti-angiogenic targeted agent, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.
- Untreated central nervous system (CNS) metastases.
- Major surgery or severe trauma within 4 weeks prior to first study drug administration.
- Current use of immunosuppressive agents, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose >10 mg/day prednisone or equivalent), and continued use within 2 weeks before enrollment.
- Presence of any active autoimmune disease or history of autoimmune disease.
- History of other malignancies within the past 5 years, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Known inherited or acquired bleeding/thrombotic tendency (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or currently receiving thrombolytic or anticoagulant therapy.
- Currently active bleeding or significant bleeding tendency within 3 months (i.e., patients at high risk of bleeding).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Fruquintinib Combined With Serplulimab and XELOX
This study consists of two phases: combination and maintenance therapy. combination therapy administration： After screening and enrollment, patients will receive a first-line combination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles. Maintenance therapy administration: After completion of the combination therapy, subjects with a response assessment of CR, PR, or SD, , will enter the maintenance phase: Fruquintinib、Serplulimaband Capecitabine , until diseas progression, unacceptable toxicity, or voluntary withdrawal of informed consent NOTE: If lesions become resectable, surgical treatment should be performed. |
combination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles. The dosing schedule is as follows: Fruquintinib: 3 mg/day, QD, PO, daily for 21 days of each 28-day cycle Serplulimab: 4.5 mg/kg, D1, intravenous infusion, Q3W XELOX ：Oxaliplatin: 130 mg/m², intravenous infusion over 0-2 hours, D1, Q3W Capecitabine: 1000 mg/m², PO, BID, D1-14, Q3W Maintenance therapy administration: After completion of the combination therapy, subjects with a response assessment of CR, PR, or SD, , will enter the maintenance phase: Fruquintinib、Serplulimaband Capecitabine , until diseas progression, unacceptable toxicity, or voluntary withdrawal of informed consent |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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연구자 평가 무진행 생존기간(PFS)
기간: 등록부터 18개월 치료 종료까지
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암 환자의 치료 시작부터 질병 진행 또는 어떠한 원인으로 인한 사망 관찰까지의 시간
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등록부터 18개월 치료 종료까지
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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연구자 평가 객관적 반응률（ORR）
기간: 18개월 치료 종료 시점까지 등록부터
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CR+PR
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18개월 치료 종료 시점까지 등록부터
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전체 생존율(OS)
기간: 등록부터 36개월 치료 종료까지
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등록부터 모든 원인에 의한 사망까지의 시간
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등록부터 36개월 치료 종료까지
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DCR
기간: From enrollment to the end of treatment at 24 months
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CR+PR+SD
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From enrollment to the end of treatment at 24 months
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AEs
기간: Through study completion, an average of 30 weeks
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Safety analysis will be based on data from the safety population.
It will primarily involve descriptive statistical analysis, with tables describing the adverse events that occurred in this study.
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Through study completion, an average of 30 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .