NCT07789184尚未招募3 期
A Prospective, Multicenter, Phase III Randomized Controlled Trial Evaluating the Impact of Radical Surgery Versus Non-Surgery on Prognosis and Quality of Life in Gastric Cancer Patients With Peritoneal Metastasis After Successful Conversion Therapy (ALANO Study, CGCA2603 Study)
Hua Huang, MD, PhD31 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2026年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 31
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The goal of this clinical trial is to learn if radical surgery improves prognosis and quality of life compared with continued standard non-surgical treatment in gastric cancer patients with peritoneal metastasis who have achieved successful conversion therapy. The main questions it aims to answer are:
- Does radical surgery prolong overall survival in patients who achieve successful conversion therapy?
- Does radical surgery provide better or at least comparable quality of life and safety outcomes compared with continued standard treatment? Researchers will compare radical surgery versus continued standard systemic treatment to see whether radical surgery provides superior clinical benefit for patients after successful conversion therapy.
Participants will:
- Initial laparoscopic exploration confirms CY0P1 or CY1P1, absence of distant organ metastasis, a PCI ≤ 20, and presence or absence of ascites.
- Receive conversion therapy (chemotherapy, targeted/immunotherapy, intraperitoneal therapy, etc.) per standard guidelines, tailored to the patient's condition and molecular-pathological profile
- If clinical conversion is confirmed, undergo a second laparoscopic exploration to verify successful conversion
- If successful conversion is confirmed (peritoneal lesions cleared or markedly regressed with negative biopsy, no ascites or distant metastases, R0-resectable primary tumor, and improved patient condition), be randomized 1:1 to either the surgery group or the standard treatment group
- In the surgery group, undergo curative gastrectomy with D2 lymphadenectomy during the second laparoscopy, followed by adjuvant therapy and maintenance treatment
- In the standard treatment group, continue systemic therapy without surgery, with maintenance treatment and salvage surgery permitted if clinically indicated
- Complete quality of life questionnaires at predefined time points
- Be followed up for survival, disease progression, adverse events and medical resource use outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance.
- •Age ≥ 18 years and ≤ 70 years.
- •Histologically and/or cytologically confirmed gastric cancer.
- •No evidence of gastric outlet obstruction or intestinal obstruction.
- •No distant metastasis on imaging examination. Initial laparoscopic exploration confirms CY0P1 or CY1P1, without distant organ metastasis, with a recorded peritoneal carcinomatosis index (PCI) ≤ 20, and with either positive or negative ascites. Patients meeting these criteria are eligible for pre-enrollment. Following successful conversion therapy, a second laparoscopic exploration must confirm conversion to CY0P0, with no distant organ metastases and no regional lymph node metastases beyond the second station. Only upon meeting these criteria are patients formally enrolled in the study.
- •No prior chemotherapy, targeted therapy, or immunotherapy.
- •ECOG performance status score of 0-
- •Life expectancy ≥ 12 weeks.
- •Laboratory requirements: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 8 g/dL; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 1.5 × ULN. In the presence of liver metastases, AST and ALT ≤ 5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (CCr) ≥ 60 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
排除标准
- •Initial laparoscopic exploration reveals P0, or either of the two laparoscopic explorations reveals distant organ metastasis or distant lymph node metastasis.
- •Prior anticancer therapy, including chemotherapy, targeted therapy, or immunotherapy.
- •Hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
- •Active bleeding or coagulation disorder within 2 months prior to enrollment, bleeding tendency, or ongoing thrombolytic therapy, deemed by the investigator as unsuitable for enrollment.
- •Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris. Left ventricular ejection fraction (LVEF) < 50% on echocardiography, or poorly controlled arrhythmia.
- •Known allergy to immunotherapy agents, chemotherapy agents, or any of their excipients.
- •Pregnancy (positive pregnancy test prior to treatment initiation) or breastfeeding.
- •Active or uncontrolled severe infection: Severe infection within 4 weeks prior to enrollment (e.g., requiring intravenous antibiotics, antifungals, or antivirals); Known human immunodeficiency virus (HIV) infection; History of clinically significant liver disease, including viral hepatitis. For known hepatitis B virus (HBV) carriers, active HBV infection must be excluded, defined as HBV DNA positive (> 1 × 10⁴ copies/mL or > 2000 IU/mL); Known hepatitis C virus (HCV) infection with positive HCV RNA (> 1 × 10³ copies/mL), or other hepatitis, cirrhosis.
- •Urinalysis indicating proteinuria ≥ 2+, with 24-hour urine protein quantification > 1.0 g.
- •Any other condition deemed by the investigator as inappropriate for participation in this study.
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 3 years after randomization
次要结局
- Quality of Life (QoL) assessed by EORTC QLQ-C30 questionnaires(Prior to first-look laparoscopy, prior to second-look laparoscopy, 1-month post-randomization, 3-months post-randomization, then every 3-months thereafter up to 3-years after randomization)
- Quality of Life (QoL) assessed by EORTC QLQ-STO22 questionnaires(Prior to first-look laparoscopy, prior to second-look laparoscopy, 1-month post-randomization, 3-months post-randomization, then every 3-months thereafter up to 3-years after randomization)
- Pathological Complete Response (pCR) Rate(At the time of radical surgery)
- R0 Resection Rate(At the time of radical surgery)
- Complication-Free Survival(Up to 3 years after randomization)
- Major Complication Rate(Within 30 days and 90 days after surgery)
- Progression-Free Survival (PFS) and Peritoneal PFS(Up to 3 years after randomization)
- Time to Peritoneal Re-dissemination(Up to 3 years after randomization)
- Length of Hospital Stay(Perioperative period)
- Readmission Rate(Within 30 days and 90 days post-surgery)
- Treatment Interruption Rate(Within 1-year after randomization)
- Direct Medical Costs / Hospitalization Costs(Baseline through study completion, an average of 3-years post-randomization)
研究者
Hua Huang, MD, PhD
Professor, Department of Gastric Surgery, Fudan University Shanghai Cancer Center
Shanghai Cancer Hospital, China
研究点 (31)
Loading locations...
相似试验
尚未招募
3 期
Study on surgical procedure for eye surface healing and regenerationCTRI/2025/11/098224MediNippon Healthcare Pvt. Ltd.6
招募中
3 期
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon CancerNCT07412613Akeso386
招募中
不适用
A Study to Investigate the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP PatientsNCT07446738AstraZeneca200
招募中
2 期
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)NCT07263919Akeso90
Enrolling By Invitation
不适用
Comparison of the Effect of Surgical Resection Based on Lesion Extent Before and After Neoadjuvant Therapy in Patients With Stage II-IIIB Non-Small Cell Lung Cancer: A Single-Center, Real-World, Open-Label StudyNCT07373899Cancer Institute and Hospital, Chinese Academy of Medical Sciences354