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ClinicalTrials.gov ID

NCT07789184

Lead Sponsor

Hua Huang, MD, PhDOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

170Estimated

Last Update Posted

Aug 27, 2026Actual

Start Date

Oct 1, 2026Estimated

Primary Completion Date

Oct 1, 2031Estimated

Completion Date

Oct 1, 2031Estimated

Official Title

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)

Brief Summary

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

• Gastric Cancer
• Peritoneal Metastasis

• Radical Gastrectomy with D2 Lymphadenectomy
• Standard Systemic Therapy for Advanced Gastric Cancer

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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 0-2.
• 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.

Exclusion Criteria:

• 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Hua Huang, MD, PhDOTHER

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