NCT06774222 A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG
| NCT ID | NCT06774222 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Henan Cancer Hospital |
| Condition | Gastric/Gastroesophageal Junction Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 69 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 69 participants in total. It began in 2023-09-12 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Fei Ma, M.D.
PRINCIPAL INVESTIGATOR
Working relationship
Frequently Asked Questions
Who can join the NCT06774222 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gastric/Gastroesophageal Junction Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06774222 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06774222 currently recruiting?
Yes, NCT06774222 is actively recruiting participants. Contact the research team at mafeizzu@outlook.com for enrollment information.
Where is the NCT06774222 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT06774222 clinical trial?
NCT06774222 is sponsored by Henan Cancer Hospital. The principal investigator is Fei Ma, M.D. at Working relationship. The trial plans to enroll 69 participants.