An observational study in Helicobacter Pylori and Early Gastric Cancer, sponsored by Jilin University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Jilin University · Observational
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Among 1,183 studies in Stomach Neoplasms with a site in China — 480 open to participants now, 556 under way, 50 of them phase 3. Stomach Neoplasms · China.
Among the 1,183 studies in Stomach Neoplasms with a site in China, this one is the 181st largest by planned enrollment of the 303 observational ones that give a count, is one of 118 that started in 2025, is one of 303 observational ones, reaches primary completion later than 179 of the 555 other live ones, and was the 1,060th registered.
3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.
Browse Stomach Neoplasms studies →480 of the 1,183 studies in Stomach Neoplasms with a site in China are open now. Recruiting first, the newest first:
Hua Huang, MD, PhD · Sites in China
Ages 18–70
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80 · Healthy volunteers
Akeso · Sites in China, United States, Germany and 1 more country
Ages 18+
Peking University First Hospital · Sites in China
Ages 18–75 · Healthy volunteers
Jie Yuan，MD · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,183 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 167 · Phase 2 420 · Phase 3 146 · Phase 4 24
First in 1997; this study’s year is marked. 118 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 231 is below the median of 276 across 791 observational studies indexed under Stomach Neoplasms.
Median enrollment 87 across the 880 interventional studies, 300 across the 303 observational. Of the 270 that completed or were terminated, 28 (10%) have results posted.
This tab as a report to print or save as PDF → With an account.
210 of 1,183 have an industry lead sponsor. The 10 most frequent:
Jilin University is the lead sponsor of 27 studies on the registry; 12 are open to participants now.
Jilin University has 5 studies filed under Stomach Neoplasms — fewer than ten, so there is no comparison to draw.
124 of the studies in Stomach Neoplasms with a site in China that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06221748Phase 3RemeGen Co., Ltd.DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy | 2026-12 |
| NCT05918094Phase 3Sun Yat-sen UniversityComparing Modified XELOX Plus Sintilimab With Standard XELOX Plus Sintilimab in First-line Treatment for HER2-negative Gastric/Gastroesophageal Junction Adenocarcinoma | 2026-12 |
| NCT06939439Phase 3The First Affiliated Hospital with Nanjing Medical UniversityUsing ctDNA to Guide Treatment Decisions for Stage III Gastric Cancer | 2026-12-31 |
| NCT06177041Phase 3FutureGen Biopharmaceutical (Beijing) Co., LtdM108 Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. | 2027-01-11 |
| NCT06532006Phase 3Shanghai Henlius BiotechA Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer | 2027-06-01 |
Add all 124 to your calendar (.ics) → With an account.
Among the 1,183 studies in Stomach Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aimed to analyze the distribution characteristics of Helicobacter pylori（H. pylori） in varying stages of atrophic gastritis and early gastric cancer using immunohistochemical staining, with the goal of providing guidance for the early screening of gastric cancer.
A retrospective analysis was conducted on gastric biopsy cases that underwent H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025. Cases were classified into non-atrophic and atrophic groups based on the presence or absence of gastric atrophy. All cases were further divided into non-open and open atrophy groups and additionally into early gastric cancer and non-cancer groups. The distribution of H. pylori across subgroups was compared, and multivariate analyses were performed to identify risk factors associated with the development of early gastric cancer.
A retrospective analysis was performed on cases that underwent gastric H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025.
Immunohistochemical results were reviewed independently by two experienced pathologists, with disagreements resolved by a third. After applying inclusion and exclusion criteria, cases were classified according to the Kimura-Takemoto classification : First, patients were categorized into non-atrophic and atrophic groups based on the presence of atrophy. Second, all cases were further divided into non-open and open atrophy groups. Open atrophy was defined as a degree of O1 or greater (endoscopic atrophic border extending beyond the cardia). All cases were additionally categorized into early gastric cancer and non-cancer groups depending on whether early gastric cancer lesions were present or had previously been identified. Early gastric cancer was defined based on endoscopic submucosal dissection (ESD) indications: (i) UL0 cT1a differentiated-type carcinomas; (ii) UL1 cT1a differentiated-type carcinomas with a long diameter ≤3 cm; or (iii) UL0 cT1a undifferentiated-type carcinomas with a long diameter ≤2 cm. Immunohistochemical staining was performed using an anti-H. pylori antibody (Beijing Zhongshan Golden Bridge Biotechnology Co., Ltd, Beijing, China). Positive results were graded as mild (1+): occasional bacteria or colonization in \<1/3 of the specimen length; moderate (2+): colonization exceeding 1/3 but \<2/3 of the specimen, or continuous but sparse distribution on the epithelial surface; and severe (3+): clusters of H. pylori distributed across the full length of the specimen. The gastric body and antrum were assessed separately, and distribution patterns were classified as gastric antrum > gastric body, gastric antrum = gastric body, or gastric body > gastric antrum. The distribution of H. pylori across subgroups was compared, and multivariate analyses were performed to identify risk factors associated with the development of early gastric cancer.
Cases that underwent gastric H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: immunohistochemical testing
Immunohistochemical results were reviewed independently by two experienced pathologists, with disagreements resolved by a third. Immunohistochemical staining was performed using an anti-H. pylori antibody (Beijing Zhongshan Golden Bridge Biotechnology Co., Ltd, Beijing, China). Positive results were graded as mild (1+): occasional bacteria or colonization in \<1/3 of the specimen length; moderate (2+): colonization exceeding 1/3 but \<2/3 of the specimen, or continuous but sparse distribution on the epithelial surface; and severe (3+): clusters of H. pylori distributed across the full length of the specimen. The gastric body and antrum were assessed separately, and distribution patterns were classified as gastric antrum \> gastric body, gastric antrum = gastric body, or gastric body \> gastric antrum. The distribution of H. pylori across subgroups was compared, and multivariate analyses were performed to identify risk factors associated with the development of early gastric cancer.
The status of Helicobacter pylori(H. pylori)
The status of H. pylori included negative and positive status. Positve results were graded as mild (1+): occasional bacteria or colonization in \<1/3 of the specimen length; moderate (2+): colonization exceeding 1/3 but \<2/3 of the specimen, or continuous but sparse distribution on the epithelial surface; and severe (3+): clusters of H. pylori distributed across the full length of the specimen. The gastric body and antrum were assessed separately.
Time frame: one week after the endoscopic submucosal dissection (ESD)
the percentage of H. pylori positive status of gastric antrum in early gastric cancer
the percentage of H. pylori positive status of gastric antrum in early gastric cancer was assessed
Time frame: one year after the endoscopic submucosal dissection (ESD)
the percentage of H. pylori positive status of gastric body in early gastric cancer
the percentage of H. pylori positive status of gastric body in early gastric cancer was assessed
Time frame: one year after the endoscopic submucosal dissection (ESD)
the percentage of H. pylori positive status of gastric antrum in gastritis
the percentage of H. pylori positive status of gastric antrum in gastritis was assessed
Time frame: one year after the endoscopic submucosal dissection (ESD)
the percentage of H. pylori positive status of gastric body in gastritis
the percentage of H. pylori positive status of gastric body in gastritis was assessed
Time frame: one year after the endoscopic submucosal dissection (ESD)
Plan to share: No
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Started Oct 2025 (actual). Primary completion is estimated for Dec 2025, 2 months after the start.
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Jilin University