Clinical trial · Interventional
A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG
A Phase II, Single-Arm, Single-Center Study of Fruquintinib Combined With Standard Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer Patients With Poor Tumor Regression Grade.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric/Gastroesophageal Junction Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fruquintinib | Drug | Fruquintinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Fruquintinib Combined with Standard Chemotherapy
- interventionNames
- Drug: Fruquintinib
Primary outcomes (1)
- measure
- 3-year recurrence-free survival rate
- timeFrame
- Three years after surgery
- description
- Percentage of recurrence-free patients within 3 years of surgery
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- OS is the time interval from the start of treatment to death due to any reason or lost of follow-up,whichever came first, assessed up to 3 years"
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Fully understand the study and voluntarily sign the informed consent form; 2. Age between 18 and 75 years; 3. Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma; 4. Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy; 5. R0 resection after neoadjuvant chemotherapy; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. Life expectancy of at least 2 years; 8. No prior anti-cancer treatment received; 9. Good compliance and cooperation with follow-up. Exclusion Criteria: 1. Inability to comply with the study protocol or procedures; 2. History of prior gastric cancer surgery; 3. Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery; 4. Distant metastasis to organs other than the liver, such as lung, brain, and bone; 5. Known HER2-positive patients; 6. Uncontrolled hypertension despite medication prior to enrollment; 7. Poorly controlled diabetes despite medication prior to enrollment; 8. Urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification \>1.0g; 9. Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment; 10. Patients deemed ineligible for this study by the investigator.
References
Publications (0)
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