RecruitingPhase 2NCT06646588

Fruquintinib in Combination With Tislelizumab Followed by Radiotherapy in Esophageal Squamous Cell Carcinoma

Fruquintinib in Combination With Tislelizumab Followed by Radiotherapy in Relapsed or Progressive Esophageal Squamous Cell Carcinoma


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

67 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

According to the Global Burden of Disease Study, the number of esophageal cancer cases globally increased from 319,969 in 1990 to 534,563 in 2019, a relative increase of 67.07 per cent. In addition, GLOBOCAN 2020 reported that the global incidence of esophageal cancer climbed to 604,100, accounting for 3.1% of all tumor sites and ranking 7th out of 36 cancers. In addition, the number of global deaths from esophageal cancer increased from 319,332 in 1990 to 498,067 in 2019, a relative increase of 55.97%.GLOBOCAN 2020 reported about 544,076 new esophageal cancer deaths, which accounted for 5.5% of all study centres and ranked 6th among 36 cancers. Chemotherapy is the standard of care for advanced esophageal squamous cell carcinoma, but conventional chemotherapy has limited efficacy, and studies have shown lower median overall survival with chemotherapy in patients with advanced esophageal cancer compared to patients with other stages. In recent years, with the first-line approval of immune checkpoint inhibitors, the treatment of esophageal cancer has entered the immune era. Immune checkpoint inhibitors have become an important therapeutic option for patients with advanced esophageal cancer who have failed chemotherapy. This study will explore the efficacy and safety of this small molecule anti-angiogenic drug, fruquintinib, in combination with tislelizumab in esophageal squamous cell carcinoma previously treated with immune checkpoint inhibitors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of fruquintinib (a targeted blood vessel inhibitor) and tislelizumab (an immunotherapy drug) followed by radiation therapy in patients with limited-stage small cell lung cancer — a fast-growing lung cancer that hasn't yet spread widely — who have already received standard chemotherapy. **You may be eligible if...** - You are 18 years or older - You have limited-stage small cell lung cancer (confined to one side of the chest) - You have previously received chemotherapy including cisplatin or carboplatin plus etoposide - You have at least one measurable tumor on imaging - You have not received prior immunotherapy - You are in good physical health (ECOG score 0–1) and weigh more than 40 kg - Your heart, liver, kidney, and lung function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has already spread extensively - You have received prior immunotherapy - You have significant abnormalities in blood counts, heart, liver, kidney, or lung function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFruquintinib

Fruquintinib: Oral, once daily, 2 weeks on and 1 week off. The product can be taken with food or orally on an empty stomach, and needs to be swallowed whole. It is recommended that the dose be taken at the same time each day; if the patient vomits after taking the dose, no refill is needed; a missed dose should not be added the next day, but the next prescribed dose should be taken as usual.

DRUGTislelizumab

Tislelizumab: intravenous drip 200mg,day1,once every three weeks.

RADIATIONRadiotherapy

Radiotherapy synchronised with drugs.


Locations(1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06646588


Related Trials