AzTrials
AzTrials

Gastric CancerPhase 3NCT07789184

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

A Phase 3 study testing Radical Gastrectomy with D2 Lymphadenectomy and Standard Systemic Therapy for Advanced Gastric Cancer in people with Gastric Cancer and Peritoneal Metastasis, run by Hua Huang, MD, PhD at 31 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Cancer, Peritoneal Metastasis
What is being tested?
Radical Gastrectomy with D2 Lymphadenectomy and Standard Systemic Therapy for Advanced Gastric Cancer
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
31 sitesChina
Study dates
1 Dec 2026to 1 Oct 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

31 sites in 1 country. Contact the study team or a site near you to ask about taking part.

31 sites in 1 country

China31 sites, 31 recruiting
  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    ziyu li, +86 010-88121122, ziyu_li@hsc.pku.edu.cn

    Not yet recruiting
  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    xiaohui du, +86 010-68182255, duxiaohui301@sina.com

    Not yet recruiting
  • Peking University International Hospital

    Beijing, Beijing Municipality, 102206

    ning ning, +86 010-69006666, ningning301@126.com

    Not yet recruiting
  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

    quan wang, +86 0431-88782222, wquan@jlu.edu.cn

    Not yet recruiting
  • Changzhi People's Hospital

    Changzhi, Shanxi, 046000

    liang zong, +86 0355-2024990, 250537471@qq.com

    Not yet recruiting
  • The First Affiliated Hospital of Army Medical University

    Chongqing, Chongqing Municipality, 400038

    yan shi, +86 023-68765109, shiyanpwk@tmmu.edu.cn

    Not yet recruiting
  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

    pin liang, +86 0411-83635963, sunnyliangpin@163.com

    Not yet recruiting
  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    huiyan luo, +86 020-87343571, luohy@sysucc.org.cn

    Not yet recruiting
  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    yanfeng hu, +86 020-61641888, banby@smu.edu.cn

    Not yet recruiting
  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    shi chen, +86 020-38254000, chensh47@mail.sysu.edu.cn

    Not yet recruiting
  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    jiaqi chen, +86 0571-87783777, 2311046@zju.edu.cn

    Not yet recruiting
  • Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    linghua zhu, +86 0571-86090073, 3198020@zju.edu.cn

    Not yet recruiting
  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    panpan yu, +86 0571-88122222, yupp0571@163.com

    Not yet recruiting
  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong, 250014

    jiankang zhu, +86 0531-89268763, 249217523@qq.com

    Not yet recruiting
  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

    changqing jing, +86 0531-87938911, jingchangqing@sdfmu.edu.cn

    Not yet recruiting
  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    zhengrong li, +86 0791-88692748, lzr13@foxmail.com

    Not yet recruiting
  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    bin lai, +86 0791-86120120, Vincent83126@163.com

    Not yet recruiting
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School

    Nanjing, Jiangsu, 210008

    jia wei, +86 025-83106666, jiawei99@nju.edu.cn

    Not yet recruiting
  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

    chao yue, +86 025-83283597, yuechaomeng@126.com

    Not yet recruiting
  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    hao xu, +86 025-83718836, hxu@njmu.edu.cn

    Not yet recruiting
  • Nantong First People's Hospital

    Nantong, Jiangsu, 226001

    shichun feng, +86 0513-81111888, fsc2200@126.com

    Not yet recruiting
  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    zhaojian niu, +86 0532-82911847, niuzhj@hotmail.com

    Not yet recruiting
  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Hua Huang, MD, PhD, +86-13816151816, huahuang@fudan.edu.cn

    Hua Huang, MD,PHD

    Recruiting
  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

    yuan fang, +86 021-63240090, Fangyuan1231@aliyun.com

    Not yet recruiting
  • ShangRao People's Hospital

    Shangrao, Jiangxi, 334000

    jinqiang chen, +86 0793-8100469, CJQ760624@126.com

    Not yet recruiting
  • Tianjin Medical University Cancer Institute&Hospital

    Tianjin, Tianjin Municipality, 300060

    xiangyang yu, +86 022-23109106, yxynankai@126.com

    Not yet recruiting
  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

    wenbin zhang, +86 0991-7968088, zwb3216@sina.com

    Not yet recruiting
  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

    guihua wang, +86 027-83665555, ghwang@tjh.tjmu.edu.cn

    Not yet recruiting
  • The Second Affiliated Hospital of Airforce Military Medical University

    Xi'an, Shaanxi, 710038

    nan wang, +86 029-84777777, wangnandoc@fmmu.edu.cn

    Not yet recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    peng xia, +86 029-85323200, peng_xia666@126.com

    Not yet recruiting
  • Zhangzhou Affiliated hospital of Fujian Medical University

    Zhangzhou, Fujian, 363000

    lisheng cai, +86 0596-2082950, cailishengcls@163.com

    Not yet recruiting

Other trials in China

About this study

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)

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.
Read more

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
Being tested
Radical Gastrectomy with D2 Lymphadenectomy, Standard Systemic Therapy for Advanced Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radical Gastrectomy with D2 LymphadenectomyProcedure or surgery

    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.

  • Standard Systemic Therapy for Advanced Gastric CancerDrug

    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.

Study groups in NCT07789184
Study groupRoleWhat they receive
Surgery GroupExperimentalNot described
Receives: Procedure: Radical Gastrectomy with D2 Lymphadenectomy
Standard Treatment GroupActive comparatorNot described
Receives: Drug: Standard Systemic Therapy for Advanced Gastric Cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Measured: Up to 3 years after randomization

Secondary outcomes (12)
  1. Quality of Life (QoL) assessed by EORTC QLQ-C30 questionnaires

    Measured: 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

  2. Quality of Life (QoL) assessed by EORTC QLQ-STO22 questionnaires

    Measured: 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

  3. Pathological Complete Response (pCR) Rate

    Measured: At the time of radical surgery

  4. R0 Resection Rate

    Measured: At the time of radical surgery

  5. Complication-Free Survival

    Measured: Up to 3 years after randomization

  6. Major Complication Rate

    Measured: Within 30 days and 90 days after surgery

  7. Progression-Free Survival (PFS) and Peritoneal PFS

    Measured: Up to 3 years after randomization

  8. Time to Peritoneal Re-dissemination

    Measured: Up to 3 years after randomization

  9. Length of Hospital Stay

    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.

    Measured: Perioperative period

  10. Readmission Rate

    Measured: Within 30 days and 90 days post-surgery

  11. Treatment Interruption Rate

    Measured: Within 1-year after randomization

  12. Direct Medical Costs / Hospitalization Costs

    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.

    Measured: Baseline through study completion, an average of 3-years post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Oct 2031 (estimated)
  4. Study completion1 Oct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07789184
Sponsor's protocol ID
2606346-6-2608A
Status last verified
Oct 2026
First submitted
23 Aug 2026
Last updated
16 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual-participant-level raw data will not be shared externally. Aggregated study results will be published in peer-reviewed journals.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radical Gastrectomy with D2 Lymphadenectomy and Standard Systemic Therapy for Advanced Gastric Cancer in people with Gastric Cancer and Peritoneal Metastasis, run by Hua Huang, MD, PhD at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hua Huang (+86-13816151816, huahuang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 3 years after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in