Gastric CancerPhase 2NCT06957977
A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer
A Phase 2 study testing Endoscopic Cryoballoon Ablation Treatment and PD1 Inhibitor in people with Gastric Cancer and Cryoballoon Ablation, run by Zhongguang Luo, MD at 1 site in China.
Trial summary
This study evaluates the safety and efficacy of endoscopic cryoballoon ablation treatment (ECAT) combined with a PD-1 inhibitor (sintilimab) as maintenance therapy in patients with advanced gastric cancer, and further explores the underlying immunoregulatory mechanisms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Cryoballoon Ablation
- What is being tested?
- Endoscopic Cryoballoon Ablation Treatment and PD1 Inhibitor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 May 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with advanced gastric cancer (stage IV according to the AJCC 8th edition, including locally advanced unresectable gastric cancer [stage IVa] and gastric cancer with distant metastasis [stage IVb]; Borrmann classification types I, II, or III) who are deemed ineligible for surgical resection or unable to tolerate surgery, and meet the indications for first-line therapy with sintilimab combined with fluoropyrimidine- and platinum-based chemotherapy;
- Age ≥18 years;
- WHO pathological types: adenocarcinoma or neuroendocrine tumors;
- Physician-assessed estimated life expectancy greater than 3 months, with distant metastases considered controllable;
- Maximum diameter of the primary tumor ≤6 cm;
- Adequate major organ function, defined as:① Liver function: ALT and AST ≤ 2.5 times the positive range, total bilirubin ≤ 2.0mg/dL; ② Renal function: creatinine clearance ≥ 40mL/min calculated using the EPI formula;
Show all 11Show fewer
- Hematological criteria: hemoglobin (Hgb) ≥70 g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥80×10⁹/L;
- Coagulation function: prothrombin time (PT) and activated partial thromboplastin time (APTT) both <2 times the normal value;
- Negative pregnancy test for women of childbearing potential;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- Signed informed consent form.
Who cannot join
- Pregnant or breastfeeding women, or women planning to become pregnant within six months;
- Patients with infectious diseases (such as HIV, syphilis, or active tuberculosis);
- Patients with active hepatitis B or hepatitis C infection;
- Patients with other concurrent primary malignancies;
- Patients who have participated in another clinical trial within the past month;
- Patients who have taken antiplatelet or anticoagulant medications within the past week;
Show all 11Show fewer
- Patients with gastric cancer complicated by active bleeding;
- Patients with massive ascites (ascites volume ≥3000 mL);
- Patients with cardia obstruction or pyloric obstruction;
- Patients with active infections or autoimmune diseases;
- Patients deemed unsuitable for treatment by the investigator for any other reason.
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
Huashan Hospital, Fudan University, Shanghai
Shanghai, Shanghai Municipality, 200000
Wanwei Zheng, +86 13816431448, calebzww@yeah.net
About this study
This study evaluates the safety and efficacy of endoscopic cryoballoon ablation treatment (ECAT) combined with a PD-1 inhibitor (sintilimab) as maintenance therapy in patients with advanced gastric cancer, and further explores the underlying immunoregulatory mechanisms.
Read the detailed description
This study is a single-center, randomized, controlled, open-label, prospective clinical trial. A total of 42 patients with advanced gastric cancer will be enrolled. Among them, 30 patients who achieve a partial response (PR) after receiving standard of care (SOC) treatment - such as FOLFOX, POLF, FLOT, SOX, CAPOX, or FOLFIRI - will be randomly assigned to two groups. Twenty patients will receive local gastric endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab, while the remaining ten patients will receive sintilimab monotherapy. Both groups will subsequently undergo standard maintenance therapy, followed by assessments of treatment efficacy, safety, and immunological evaluations of both peripheral blood and tumor tissues. Patients whose disease status is assessed as stable disease (SD) or progressive disease (PD) after SOC treatment will proceed to receive standard second-line therapies.
- Conditions
- Gastric Cancer, Cryoballoon Ablation
- Being tested
- Endoscopic Cryoballoon Ablation Treatment, PD1 Inhibitor
- Keywords
- Cryoballoon ablation, ECAT, PD-1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Cryoballoon Ablation TreatmentProcedure or surgery
Also called ECAT
ECAT: A cryoballoon with catheter is inserted along the endoscopic forceps channel, the balloon is placed on the surface of the tumor, and the balloon is dilated so that it fits snugly over the lesion. The freezing cycle is initiated and continued for 2-3 minutes, and then the balloon is rewarmed and frozen again for 2-3 minutes; the freeze-rewarm cycle is repeated twice. PD-1:The first PD-1 monoclonal antibody treatment in this study was given within 3 days before and after ECAT treatment, and subsequent treatment was given every three weeks according to the instructions.
PD1 InhibitorDrug
The first administration of the PD-1 monoclonal antibody is initiated when patients achieve a partial response (PR) following standard treatment. Subsequent administrations are given every three weeks according to the prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| ECAT + PD-1 | Experimental | Patients who achieve a partial response (PR) following standard treatment will subsequently receive gastric local endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab. Sintilimab will be administered within three days before and after the ECAT procedure, and continued regularly thereafter. Receives: Procedure: Endoscopic Cryoballoon Ablation Treatment; Drug: PD1 Inhibitor |
| PD-1 | Active comparator | The remaining 10 patients who achieve a partial response (PR) following standard treatment will receive sintilimab monotherapy, followed by standard maintenance therapy. Receives: Drug: PD1 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is measured from the start of treatment until the first documented evidence of disease progression (based on RECIST 1.1) or death from any cause, whichever occurs first.
Measured: From enrollment to study completion, assessed up to 2 years
Overall-Survival (OS)
The length of time from the start of treatment until death from any cause.
Measured: From enrollment to study completion, assessed up to 5 years
Secondary outcomes (3)
Percentage of participants achieving complete remission (CR) and partial remission (PR) after treatment
Objective remission rate (ORR), the percentage of participants whose tumors shrink by a certain amount and remain there for a certain period of time, including complete remission (CR) and partial remission (PR). CR (Complete remission): Complete disappearance of the target lesion, with no new lesions produced, and lasting for more than 4 weeks. PR (Partial remission): the sum of the largest diameters of the target lesions is reduced by more than 30%, and lasts for more than 4 weeks.
Measured: 3 to 24 weeks after the end of treatment
Percentage of participants achieving remission (PR+CR) and lesion stabilization (SD) after treatment
Disease control rate (DCR) is the percentage of participants who achieve remission (PR+CR) and stabilization of lesions (SD) after the treatment. Stable disease (SD) means that the sum of the largest diameters of the tumor lesions has not shrunk to PR, or has not enlarged to PD.
Measured: 3 to 24 weeks after the end of treatment
Number of participants with treatment-related adverse events
The number of patients who experience ECAT-related adverse events (such as intraoperative bleeding, intraoperative perforation, postoperative bleeding, etc.)
Measured: From the start of treatment to 24 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will first receive standard treatment regimens (such as FOLFOX, POLF, FLOT, SOX, CAPOX, or FOLFIRI). Among these, 30 patients with advanced gastric cancer who achieve a partial response (PR) following standard treatment will undergo peripheral blood and local tumor tissue immunological evaluations, and will then be randomly assigned into two groups. Twenty patients will receive gastric local endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab, while ten patients will receive sintilimab monotherapy. Subsequently, both groups will continue with standard maintenance therapy, followed by assessments of treatment efficacy and safety.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongguang Luo, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhongguang Luo, MD, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957977
- Sponsor's protocol ID
- KY2025-081
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06957977
- Acronym / sponsor ID
- KY2025-081
- Conditions
- Gastric Cancer, Cryoballoon Ablation
- Keywords
- Cryoballoon ablation, ECAT, PD-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Zhongguang Luo, MDUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 May 2025 (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 evaluates the safety and efficacy of endoscopic cryoballoon ablation treatment (ECAT) combined with a PD-1 inhibitor (sintilimab) as maintenance therapy in patients with advanced gastric cancer, and further explores the underlying immunoregulatory mechanisms.
Detailed description
This study is a single-center, randomized, controlled, open-label, prospective clinical trial. A total of 42 patients with advanced gastric cancer will be enrolled. Among them, 30 patients who achieve a partial response (PR) after receiving standard of care (SOC) treatment - such as FOLFOX, POLF, FLOT, SOX, CAPOX, or FOLFIRI - will be randomly assigned to two groups. Twenty patients will receive local gastric endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab, while the remaining ten patients will receive sintilimab monotherapy. Both groups will subsequently undergo standard maintenance therapy, followed by assessments of treatment efficacy, safety, and immunological evaluations of both peripheral blood and tumor tissues. Patients whose disease status is assessed as stable disease (SD) or progressive disease (PD) after SOC treatment will proceed to receive standard second-line therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will first receive standard treatment regimens (such as FOLFOX, POLF, FLOT, SOX, CAPOX, or FOLFIRI). Among these, 30 patients with advanced gastric cancer who achieve a partial response (PR) following standard treatment will undergo peripheral blood and local tumor tissue immunological evaluations, and will then be randomly assigned into two groups. Twenty patients will receive gastric local endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab, while ten patients will receive sintilimab monotherapy. Subsequently, both groups will continue with standard maintenance therapy, followed by assessments of treatment efficacy and safety.
| Arm | Type | Receives |
|---|---|---|
| ECAT + PD-1 | Experimental | Procedure: Endoscopic Cryoballoon Ablation Treatment, Drug: PD1 InhibitorPatients who achieve a partial response (PR) following standard treatment will subsequently receive gastric local endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab. Sintilimab will be administered within three days before and after the ECAT procedure, and continued regularly thereafter. |
| PD-1 | Active comparator | Drug: PD1 InhibitorThe remaining 10 patients who achieve a partial response (PR) following standard treatment will receive sintilimab monotherapy, followed by standard maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients diagnosed with advanced gastric cancer (stage IV according to the AJCC 8th edition, including locally advanced unresectable gastric cancer [stage IVa] and gastric cancer with distant metastasis [stage IVb]; Borrmann classification types I, II, or III) who are deemed ineligible for surgical resection or unable to tolerate surgery, and meet the indications for first-line therapy with sintilimab combined with fluoropyrimidine- and platinum-based chemotherapy;
- Age ≥18 years;
- WHO pathological types: adenocarcinoma or neuroendocrine tumors;
- Physician-assessed estimated life expectancy greater than 3 months, with distant metastases considered controllable;
- Maximum diameter of the primary tumor ≤6 cm;
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding women, or women planning to become pregnant within six months;
- Patients with infectious diseases (such as HIV, syphilis, or active tuberculosis);
- Patients with active hepatitis B or hepatitis C infection;
- Patients with other concurrent primary malignancies;
- Patients who have participated in another clinical trial within the past month;
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 |
|---|---|---|
| Endoscopic Cryoballoon Ablation TreatmentAlso: ECATECAT: A cryoballoon with catheter is inserted along the endoscopic forceps channel, the balloon is placed on the surface of the tumor, and the balloon is dilated so that it fits snugly over the lesion. The freezing cycle is initiated and continued for 2-3 minutes, and then the balloon is rewarmed and frozen again for 2-3 minutes; the freeze-rewarm cycle is repeated twice. PD-1:The first PD-1 monoclonal antibody treatment in this study was given within 3 days before and after ECAT treatment, and subsequent treatment was given every three weeks according to the instructions. | Procedure or surgery | ECAT + PD-1 |
| PD1 InhibitorThe first administration of the PD-1 monoclonal antibody is initiated when patients achieve a partial response (PR) following standard treatment. Subsequent administrations are given every three weeks according to the prescribing information. | Drug | ECAT + PD-1, PD-1 |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From enrollment to study completion, assessed up to 2 years
PFS is measured from the start of treatment until the first documented evidence of disease progression (based on RECIST 1.1) or death from any cause, whichever occurs first.
Overall-Survival (OS)
Time frame: From enrollment to study completion, assessed up to 5 years
The length of time from the start of treatment until death from any cause.
3 secondary outcomes
Percentage of participants achieving complete remission (CR) and partial remission (PR) after treatment
Time frame: 3 to 24 weeks after the end of treatment
Percentage of participants achieving remission (PR+CR) and lesion stabilization (SD) after treatment
Time frame: 3 to 24 weeks after the end of treatment
Number of participants with treatment-related adverse events
Time frame: From the start of treatment to 24 weeks after the end of treatment
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 6 May 2025.
Related trials for Gastric Cancer
RecruitingObservational study
68Ga-labeled Cholecystokinin Receptor (CCK2R) Targeted Molecular Probes in Early Tumor Diagnosis
Medullary Thyroid Carcinoma, Small Cell Lung Cancer ( SCLC )
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Gastric Cancer, Postoperative Delirium
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endoscopic Cryoballoon Ablation Treatment and PD1 Inhibitor in people with Gastric Cancer and Cryoballoon Ablation, run by Zhongguang Luo, MD 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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 6 May 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From enrollment to study completion, assessed up to 2 years). The study lists 2 primary outcomes in all. 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 6 May 2025.