Combining Fruquintinib with chemotherapy for treating gastric cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of Fruquintinib in combination with standard chemotherapy as an adjuvant treatment for patients with HER2-negative gastric cancer who have a poor tumor regression grade (TRG) following surgery. The primary goal is to evaluate the recurrence-free survival (RFS) of these patients after receiving this combined therapy. Secondary objectives include assessing overall survival (OS) and the safety profile of the treatment. The study aims to provide a new therapeutic approach to improve outcomes for patients who are at high risk of tumor recurrence.

Why it matters

Who can join: the full rules

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.

Where it's running

• Henan Cancer Hospital
  Zhengzhou, China Recruiting

Study contacts

• Principal investigator: Fei Ma, M.D. — Working relationship
• Study coordinator: Fei Ma, M.D.
• Email: mafeizzu@outlook.com
• Phone: +8613703923592

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Candonilimab with Fruquintinib and Paclitaxel Albumin-Bound as second-line treatment for advanced gastric cancer

  This phase 2 trial tests whether adding candonilimab to fruquintinib and nab-paclitaxel helps people with advanced gastric or gastroesophageal junction cancer who progressed after first-line therapy.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07920224

• Ivarmacitinib with Camrelizumab and Fruquintinib in advanced colorectal cancer after prior therapies

  This trial tests whether combining ivarmacitinib with camrelizumab and fruquintinib can help patients with metastatic colorectal cancer who have progressed after multiple treatments.

  Recruiting Phase 2 Renmin Hospital of Wuhan University · Wuhan, Hubei · NCT07896096

• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

  This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

• Fruquintinib plus anti-EGFR antibody for third-line metastatic colorectal cancer

  This study tests whether adding fruquintinib to cetuximab-beta helps adults with RAS wild-type metastatic colorectal cancer who have already tried and not benefited from at least two prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07724223

• Fruquintinib treatment in adults with metastatic colorectal cancer in Poland

  This study looks at whether taking fruquintinib by mouth after prior therapies helps adults with metastatic colorectal cancer in Poland live longer before the cancer progresses and overall survival, while also considering quality of life.

  Recruiting at 3 sites Takeda · Poznan, Greater Poland Voivodeship and 9 other locations · NCT07623174

• Oral Paclitaxel Plus Fruquintinib as Second-Line Treatment in Advanced Gastric/GEJ Cancer

  This trial tests whether taking an oral paclitaxel solution together with fruquintinib, chosen by the investigator, can help adults with advanced or metastatic stomach or gastroesophageal junction cancer after first-line therapy.

  Recruiting at 15 sites Harbin Medical University · Fuzhou, Fujian and 14 other locations · NCT07552402

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.