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New treatment option for Gastric/Gastroesophageal Junction Adenocarcinoma
Official title A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG
ClinicalTrials.gov ID: NCT06774222
What this study is testing
What is Fruquintinib?
Fruquintinib is an investigational medicine, being studied as a potential treatment for gastric/gastroesophageal junction adenocarcinoma.
Also referred to as HMPL-013.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- Inability to comply with the study protocol or procedures;
- History of prior gastric cancer surgery;
- Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery;
- Distant metastasis to organs other than the liver, such as lung, brain, and bone;
- Known HER2-positive patients;
- Uncontrolled hypertension despite medication prior to enrollment;
See the full eligibility criteria
- 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.
- Inability to comply with the study protocol or procedures;
- History of prior gastric cancer surgery;
- Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery;
- Distant metastasis to organs other than the liver, such as lung, brain, and bone;
- Known HER2-positive patients;
- Uncontrolled hypertension despite medication prior to enrollment;
- Poorly controlled diabetes despite medication prior to enrollment;
- Urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification \>1.0g;
- Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment;
- Patients deemed ineligible for this study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.