Radical Surgery Versus Non-Surgery in Gastric Cancer Patients With Peritoneal Metastasis After Successful Conversion Therapy

August 26, 2026 updated by: Hua Huang, MD, PhD

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)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Chinese PLA General Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 102206
        • Peking University International Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100142
        • Peking University Cancer Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400038
        • The First Affiliated Hospital of Army Medical University
        • Contact:
    • Fujian
      • Zhangzhou, Fujian, China, 363000
        • Zhangzhou Affiliated hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital, Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Cancer Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School
        • Contact:
      • Nantong, Jiangsu, China, 226001
        • Nantong First People's Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Shangrao, Jiangxi, China, 334000
        • Shangrao People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710038
        • The Second Affiliated Hospital of Airforce Military Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250021
      • Jinan, Shandong, China, 250014
        • The First Affiliated Hospital of Shandong First Medical University
        • Contact:
      • Qingdao, Shandong, China
        • The Affiliated Hospital of Qingdao University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Hua Huang, MD,PHD
      • Shanghai, Shanghai Municipality, China
    • Shanxi
      • Changzhi, Shanxi, China, 046000
        • Changzhi People'S Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute＆Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830011
        • Affiliated Cancer Hospital of Xinjiang Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery Group
Procedure: Radical Gastrectomy with D2 Lymphadenectomy
Patients undergo curative gastrectomy with D2 lymphadenectomy (laparoscopic, robotic, or open) during second-look laparoscopy after successful conversion therapy. Postoperatively, they receive adjuvant systemic therapy (continuing the preoperative regimen or MDT-modified protocol) for up to 8 cycles total, followed by maintenance therapy for up to 1 year after randomization, or until disease progression, unacceptable toxicity, or withdrawal.
Active Comparator: Standard Treatment Group
Drug: Standard Systemic Therapy for Advanced Gastric Cancer
Patients do not undergo surgery. They continue the original conversion regimen or an MDT-adjusted systemic therapy for a total of 8 cycles, followed by maintenance therapy for up to 1 year after randomization, or until disease progression, unacceptable toxicity, or withdrawal. Salvage surgery is permitted if clinically indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 3 years after randomization
Up to 3 years after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL) assessed by EORTC QLQ-C30 questionnaires
Time Frame: 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
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
Time Frame: 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
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
Time Frame: At the time of radical surgery
At the time of radical surgery
R0 Resection Rate
Time Frame: At the time of radical surgery
At the time of radical surgery
Complication-Free Survival
Time Frame: Up to 3 years after randomization
Up to 3 years after randomization
Major Complication Rate
Time Frame: Within 30 days and 90 days after surgery
Within 30 days and 90 days after surgery
Progression-Free Survival (PFS) and Peritoneal PFS
Time Frame: Up to 3 years after randomization
Up to 3 years after randomization
Time to Peritoneal Re-dissemination
Time Frame: Up to 3 years after randomization
Up to 3 years after randomization
Length of Hospital Stay
Time Frame: Perioperative period
Duration of postoperative hospital stay, calculated from the date of surgical intervention to the date of hospital discharge, only applicable to participants receiving surgical treatment.
Perioperative period
Readmission Rate
Time Frame: Within 30 days and 90 days post-surgery
Within 30 days and 90 days post-surgery
Treatment Interruption Rate
Time Frame: Within 1-year after randomization
Within 1-year after randomization
Direct Medical Costs / Hospitalization Costs
Time Frame: Baseline through study completion, an average of 3-years post-randomization
Direct medical costs are defined as all medical expenses directly related to the patient's care, including hospitalization, surgery, medications, laboratory tests, imaging examinations, and management of complications. Data will be collected continuously throughout the study period (from baseline until death or study completion) and aggregated at the end of the study.
Baseline through study completion, an average of 3-years post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Huang, MD, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

August 23, 2026

First Submitted That Met QC Criteria

August 26, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2606346-6-2608A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual-participant-level raw data will not be shared externally. Aggregated study results will be published in peer-reviewed journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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