Gastric Cancer (GC)CGCA202501NCT07533825
Laparoscopic Staging for Stage III Gastric Cancer
A study testing Laparoscopic Staging-Guided Therapy and Without Laparoscopic Exploration in people with Gastric Cancer (GC) and Gastric Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study aims to determine, through a multicenter randomized controlled design, the impact of precision treatment guided by laparoscopic staging on overall survival (OS), surgical conversion rate, and peritoneal metastasis rate in patients with clinical stage III gastric cancer, thereby providing evidence for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer (GC), Gastric Adenocarcinoma
- What is being tested?
- Laparoscopic Staging-Guided Therapy and Without Laparoscopic Exploration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 968 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 31 Dec 2029
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed: Histologically proven adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II/III).
- Definitive pathological markers: Documented status of HER2, MMR, CPS (PD-L1) score, and Claudin 18.2.
- Clinical stage: cT3/T4a N+ M0 based on contrast-enhanced CT, endoscopic ultrasound, or MRI (AJCC 8th edition):
- cT3: Tumor invades through the muscularis propria into the subserosa. cT4a: Tumor penetrates the visceral peritoneum. cN+: Regional lymph node metastasis (intra-abdominal regional nodes such as perigastric, celiac, or common hepatic artery lymph nodes: short-axis diameter > 8 mm; other nodes such as retroperitoneal or para-aortic lymph nodes: short-axis diameter > 10 mm).
- No evidence of peritoneal metastasis on imaging modalities other than laparoscopic exploration.
- Age: 18 to 75 years, regardless of sex.
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- Performance status: ECOG score 0-2 (fully active to ambulatory and capable of self-care but unable to work).
- Life expectancy: Estimated survival ≥ 6 months.
- Surgical fitness: Adequate cardiopulmonary functional reserve and no contraindications to anesthesia.
- Informed consent: Voluntary participation with written informed consent obtained.
Who cannot join
- 1. Gastric outlet obstruction: Requiring gastrojejunostomy due to obstructive symptoms.
- 2. Distant metastasis: Evidence of peritoneal, mesenteric, or omental metastasis and/or obvious ascites on imaging, or distant organ metastasis.
- 3. Other malignancies: History of or concurrent other malignant tumors (except curatively treated basal cell carcinoma of the skin).
- 4. Organ dysfunction: Severe cardiac insufficiency (NYHA class III-IV), hepatic dysfunction Child-Pugh class C, or creatinine clearance < 30 mL/min.
- 5. Contraindications to laparoscopy: History of severe intra-abdominal adhesions, coagulation disorders (INR > 1.5 or platelet count < 50 × 10⁹/L), or severe intestinal obstruction.
- 6. Special populations: Pregnant or lactating women, or those unable to interrupt breastfeeding.
- 7. Mental status: Cognitive impairment or psychiatric disorders that preclude compliance with follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital,
Tianjin, Tianjin Municipality, 300060
About this study
Official title: A Phase III, Prospective, Multicenter, Randomized Controlled Trial of the Prognostic Impact of Laparoscopic Staging Laparoscopy in Patients With Clinical Stage III Gastric Cancer
This study aims to determine, through a multicenter randomized controlled design, the impact of precision treatment guided by laparoscopic staging on overall survival (OS), surgical conversion rate, and peritoneal metastasis rate in patients with clinical stage III gastric cancer, thereby providing evidence for precision staging and treatment decision-making.
Read the detailed description
This study aims to compare, through a multicenter randomized controlled design, patients who undergo laparoscopic exploration staging before treatment (experimental group) with patients who receive treatment directly based on imaging findings (control group).Experimental Group: Will undergo laparoscopic exploration. If peritoneal metastasis (CY+ or P+) or cT4aN+ or cT4bN+ or M1 is found, recommendations include: Systemic therapy + NIPS ± HIPEC or HIPEC. If no metastasis is found, systemic neoadjuvant therapy is recommended.Control Group: Will not undergo laparoscopic exploration. Systemic therapy will be recommended directly based on imaging staging.
The primary objective of this study is to compare the 3-year overall survival (OS) between the two groups (experimental group and control group). Overall survival is defined as the time from randomization or start of treatment to death from any cause, with the 3-year survival rate serving as the primary endpoint to evaluate the long-term survival benefit of the two treatment strategies.
The secondary objectives of this study include the following three items:1.To evaluate the detection rate of peritoneal metastasis by laparoscopic staging (experimental group only).2.To evaluate the R0 resection rate after conversion surgery in both groups.3.To compare the surgical conversion rate (i.e., the proportion of patients who change from the original treatment plan to surgery) between the two groups.
- Conditions
- Gastric Cancer (GC), Gastric Adenocarcinoma
- Being tested
- Laparoscopic Staging-Guided Therapy, Without Laparoscopic Exploration
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Staging-Guided TherapyDevice
This intervention consists of a treatment strategy guided by findings from laparoscopic staging.
If laparoscopic exploration reveals peritoneal metastasis (CY+ or P+), cT4aN+, cT4bN+, or M1 disease:
Patients receive systemic therapy combined with NIPS (neoadjuvant intraperitoneal and systemic chemotherapy) ± HIPEC (hyperthermic intraperitoneal chemotherapy), or HIPEC alone.
If laparoscopic exploration shows no peritoneal metastasis and the patient is cT3N+:
Patients receive systemic neoadjuvant therapy alone, followed by imaging evaluation every 3-4 cycles and planned surgery.
Postoperative treatment for the experimental group:
After conversion therapy and surgery, systemic therapy + NIPS ± HIPEC or HIPEC is recommended.
This intervention is distinguished from the comparator arm (which proceeds directly to systemic therapy without laparoscopic exploration and without intraperitoneal drug administration) by its use of laparoscopic staging to tailor treatment intensity and route, inc
Without Laparoscopic ExplorationDevice
Patients undergo upfront systemic therapy without laparoscopic exploration and without intraperitoneal drug administration.
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergo laparoscopic exploration | Experimental | Patients with peritoneal metastasis (CY+ or P+) or cT4aN+ or M1 disease receive systemic therapy + NIPS ± HIPEC or HIPEC alone.
In cases without peritoneal metastasis and for patients with cT3N+, systemic neoadjuvant therapy is administered. Receives: Device: Laparoscopic Staging-Guided Therapy |
| Without undergoing laparoscopic exploration | Active comparator | Without undergoing laparoscopic exploration, patients receive upfront systemic therapy without intraperitoneal drug administration.
Systemic therapy: Treatment regimen is selected based on molecular marker testing results and in accordance with gastric cancer treatment guidelines. There is no limit on the number of neoadjuvant or conversion therapy cycles; imaging evaluation is required every 3 to 4 cycles.
Surgical treatment: Surgery is performed according to each center's treatment assessment and plan. Intraoperative exploration will determine the following:
If R0 resection is achievable, D2 or D2+ radical gastrectomy is performed;
If partial response is achieved but R0 resection remains infeasible, the procedure is concluded, and conversion therapy with the original regimen or second-line therapy is continued.
Post-surgery, maintenance therapy with the original regimen is recommended until disease progression. Receives: Device: Without Laparoscopic Exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Overall Survival (OS)
To compare the 3-year Overall Survival (OS) between the two groups.
Measured: about 3 years
Secondary outcomes (3)
Laparoscopic Detection Rate of Peritoneal Metastasis
Detection Rate of Peritoneal Metastasis by Laparoscopic Exploration (DRPM-LE). This refers to the proportion of patients in whom peritoneal metastasis (including peritoneal seeding or positive peritoneal cytology) is identified via laparoscopic exploration. This outcome measure is used to assess the diagnostic value of laparoscopic staging in detecting peritoneal metastasis among patients with clinical stage III gastric cancer, and serves as a key parameter for evaluating the effectiveness of precision staging approaches.
Measured: about 3 years
R0 Resection Rate
R0 Resection Rate After Conversion Surgery
Measured: about 3 years
Laparotomy Conversion Rate
This refers to the proportion of patients in whom a laparoscopic procedure (exploration or surgery) is converted to open surgery due to factors such as extensive tumor invasion, technical difficulty, or intraoperative complications. This outcome measure assesses the safety and feasibility of laparoscopic staging and serves as a key indicator of whether precision staging effectively avoids unnecessary laparotomy in patients with clinical stage III gastric cancer.
Measured: about 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (GC)Studies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 968 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University International Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University People's Hospital, First Hospital of China Medical University, The First Hospital of Jilin University, Liaoning Cancer Hospital & Institute, Hebei Medical University Fourth Hospital, Changzhi People's Hospital, Shaanxi Provincial People's Hospital, General Hospital of Ningxia Medical University, Lanzhou University Second Hospital, Qianfoshan Hospital, Shandong Provincial Hospital, Qilu Hospital of Shandong University, Yantai Yuhuangding Hospital, Shanghai Zhongshan Hospital, RenJi Hospital, Fudan University, Anhui Provincial Hospital, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Hospital of Xuzhou Medical University, Zhejiang Cancer Hospital, Second Affiliated Hospital of Soochow University, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Jiangxi Provincial Cancer Hospital, West China Hospital, Guangdong Provincial People's Hospital, Fujian Medical University Union Hospital, Fujian Cancer Hospital, Tang-Du Hospital, Renmin Hospital of Wuhan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533825
- Sponsor's protocol ID
- E20251149
- Other IDs
- TJYXZDXK-3-003A
- Acronym
- CGCA202501
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Prospective, Multicenter, Randomized Controlled Trial of the Prognostic Impact of Laparoscopic Staging Laparoscopy in Patients With Clinical Stage III Gastric Cancer
- ClinicalTrials.gov ID
- NCT07533825
- Acronym / sponsor ID
- CGCA202501 / E20251149
- Conditions
- Gastric Cancer (GC), Gastric Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 968 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Peking University International Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University People's Hospital, First Hospital of China Medical University, The First Hospital of Jilin University, Liaoning Cancer Hospital & Institute, Hebei Medical University Fourth Hospital, Changzhi People's Hospital, Shaanxi Provincial People's Hospital, General Hospital of Ningxia Medical University, Lanzhou University Second Hospital, Qianfoshan Hospital, Shandong Provincial Hospital, Qilu Hospital of Shandong University, Yantai Yuhuangding Hospital, Shanghai Zhongshan Hospital, RenJi Hospital, Fudan University, Anhui Provincial Hospital, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Hospital of Xuzhou Medical University, Zhejiang Cancer Hospital, Second Affiliated Hospital of Soochow University, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Jiangxi Provincial Cancer Hospital, West China Hospital, Guangdong Provincial People's Hospital, Fujian Medical University Union Hospital, Fujian Cancer Hospital, Tang-Du Hospital, Renmin Hospital of Wuhan University
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine, through a multicenter randomized controlled design, the impact of precision treatment guided by laparoscopic staging on overall survival (OS), surgical conversion rate, and peritoneal metastasis rate in patients with clinical stage III gastric cancer, thereby providing evidence for precision staging and treatment decision-making.
Detailed description
This study aims to compare, through a multicenter randomized controlled design, patients who undergo laparoscopic exploration staging before treatment (experimental group) with patients who receive treatment directly based on imaging findings (control group).Experimental Group: Will undergo laparoscopic exploration. If peritoneal metastasis (CY+ or P+) or cT4aN+ or cT4bN+ or M1 is found, recommendations include: Systemic therapy + NIPS ± HIPEC or HIPEC. If no metastasis is found, systemic neoadjuvant therapy is recommended.Control Group: Will not undergo laparoscopic exploration. Systemic therapy will be recommended directly based on imaging staging.
The primary objective of this study is to compare the 3-year overall survival (OS) between the two groups (experimental group and control group). Overall survival is defined as the time from randomization or start of treatment to death from any cause, with the 3-year survival rate serving as the primary endpoint to evaluate the long-term survival benefit of the two treatment strategies.
The secondary objectives of this study include the following three items:1.To evaluate the detection rate of peritoneal metastasis by laparoscopic staging (experimental group only).2.To evaluate the R0 resection rate after conversion surgery in both groups.3.To compare the surgical conversion rate (i.e., the proportion of patients who change from the original treatment plan to surgery) between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo laparoscopic exploration | Experimental | Device: Laparoscopic Staging-Guided TherapyPatients with peritoneal metastasis (CY+ or P+) or cT4aN+ or M1 disease receive systemic therapy + NIPS ± HIPEC or HIPEC alone. In cases without peritoneal metastasis and for patients with cT3N+, systemic neoadjuvant therapy is administered. |
| Without undergoing laparoscopic exploration | Active comparator | Device: Without Laparoscopic ExplorationWithout undergoing laparoscopic exploration, patients receive upfront systemic therapy without intraperitoneal drug administration. Systemic therapy: Treatment regimen is selected based on molecular marker testing results and in accordance with gastric cancer treatment guidelines. There is no limit on the number of neoadjuvant or conversion therapy cycles; imaging evaluation is required every 3 to 4 cycles. Surgical treatment: Surgery is performed according to each center's treatment assessment and plan. Intraoperative exploration will determine the following: If R0 resection is achievable, D2 or D2+ radical gastrectomy is performed; If partial response is achieved but R0 resection remains infeasible, the procedure is concluded, and conversion therapy with the original regimen or second-line therapy is continued. Post-surgery, maintenance therapy with the original regimen is recommended until disease progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically confirmed: Histologically proven adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II/III).
- Definitive pathological markers: Documented status of HER2, MMR, CPS (PD-L1) score, and Claudin 18.2.
- Clinical stage: cT3/T4a N+ M0 based on contrast-enhanced CT, endoscopic ultrasound, or MRI (AJCC 8th edition):
- cT3: Tumor invades through the muscularis propria into the subserosa. cT4a: Tumor penetrates the visceral peritoneum. cN+: Regional lymph node metastasis (intra-abdominal regional nodes such as perigastric, celiac, or common hepatic artery lymph nodes: short-axis diameter > 8 mm; other nodes such as retroperitoneal or para-aortic lymph nodes: short-axis diameter > 10 mm).
- No evidence of peritoneal metastasis on imaging modalities other than laparoscopic exploration.
Key exclusion criteria (7 listed)
- 1. Gastric outlet obstruction: Requiring gastrojejunostomy due to obstructive symptoms.
- 2. Distant metastasis: Evidence of peritoneal, mesenteric, or omental metastasis and/or obvious ascites on imaging, or distant organ metastasis.
- 3. Other malignancies: History of or concurrent other malignant tumors (except curatively treated basal cell carcinoma of the skin).
- 4. Organ dysfunction: Severe cardiac insufficiency (NYHA class III-IV), hepatic dysfunction Child-Pugh class C, or creatinine clearance < 30 mL/min.
- 5. Contraindications to laparoscopy: History of severe intra-abdominal adhesions, coagulation disorders (INR > 1.5 or platelet count < 50 × 10⁹/L), or severe intestinal obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Staging-Guided TherapyThis intervention consists of a treatment strategy guided by findings from laparoscopic staging. If laparoscopic exploration reveals peritoneal metastasis (CY+ or P+), cT4aN+, cT4bN+, or M1 disease: Patients receive systemic therapy combined with NIPS (neoadjuvant intraperitoneal and systemic chemotherapy) ± HIPEC (hyperthermic intraperitoneal chemotherapy), or HIPEC alone. If laparoscopic exploration shows no peritoneal metastasis and the patient is cT3N+: Patients receive systemic neoadjuvant therapy alone, followed by imaging evaluation every 3-4 cycles and planned surgery. Postoperative treatment for the experimental group: After conversion therapy and surgery, systemic therapy + NIPS ± HIPEC or HIPEC is recommended. This intervention is distinguished from the comparator arm (which proceeds directly to systemic therapy without laparoscopic exploration and without intraperitoneal drug administration) by its use of laparoscopic staging to tailor treatment intensity and route, inc | Device | Patients who undergo laparoscopic exploration |
| Without Laparoscopic ExplorationPatients undergo upfront systemic therapy without laparoscopic exploration and without intraperitoneal drug administration. | Device | Without undergoing laparoscopic exploration |
Primary outcome
3-year Overall Survival (OS)
Time frame: about 3 years
To compare the 3-year Overall Survival (OS) between the two groups.
3 secondary outcomes
Laparoscopic Detection Rate of Peritoneal Metastasis
Time frame: about 3 years
R0 Resection Rate
Time frame: about 3 years
Laparotomy Conversion Rate
Time frame: about 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Staging-Guided Therapy and Without Laparoscopic Exploration in people with Gastric Cancer (GC) and Gastric Adenocarcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 10 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Overall Survival (OS) (time frame: about 3 years). 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 Apr 2026.