NCT06774222RecruitingPhase 2
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 · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (estimated)
- First submitted
- 12 Dec 2024
- Start date
- 12 Sept 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Henan Cancer Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06774222
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 69
- From 12 Sept 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior gastric cancer surgery;
- Uncontrolled hypertension despite medication prior to enrollment;
- Poorly controlled diabetes despite medication prior to enrollment;
- Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment;
Other illness
- Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery;
Other
- Inability to comply with the study protocol or procedures;
- Distant metastasis to organs other than the liver, such as lung, brain, and bone;
- Known HER2-positive patients;
- Urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification \>1.0g;
- Patients deemed ineligible for this study by the investigator.
Who the study is looking for
- Fully understand the study and voluntarily sign the informed consent form;
- Age between 18 and 75 years;
- Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma;
- Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy;
- R0 resection after neoadjuvant chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Life expectancy of at least 2 years;
- No prior anti-cancer treatment received;
- Good compliance and cooperation with follow-up.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.