Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06646588

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

Led by Hebei Medical University Fourth Hospital · Updated on 2024-10-17

67

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary participation with signed informed consent
  • Age 18 years or older, any gender
  • Histologically or cytologically confirmed limited-stage small cell lung cancer
  • Immunohistochemical results available
  • Previous chemotherapy including cisplatin or carboplatin combined with etoposide
  • ECOG performance status of 0 or 1
  • Body weight greater than 40 kg
  • Expected survival of at least 6 months
  • At least one measurable lesion according to RECIST 1.1, not previously treated with radiotherapy
  • No previous immunotherapy
  • No serious abnormalities in hematopoietic, cardiac, pulmonary, hepatic, or renal function
  • Female participants must be postmenopausal or have a negative pregnancy test if premenopausal
Not Eligible

You will not qualify if you...

  • Presence of distant organ metastases excluding supraclavicular lymph nodes
  • Prior chest radiotherapy
  • Medical contraindications to etoposide-platinum chemotherapy
  • Active or history of autoimmune disease or recent use of immunosuppressive drugs
  • Previous or current treatment with PD-1/PD-L1 antibody therapies or participation in other interventional studies
  • Received other anti-tumor therapies or systemic immunotherapy within 4 weeks before study start
  • Uncontrolled cardiac conditions including heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
  • Immune system defects, active hepatitis B or C, or active tuberculosis
  • Active infection or unexplained fever above 38.5°C within 2 weeks before screening
  • Other serious illnesses or social factors that may interfere with study participation or data collection

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050011

Actively Recruiting

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Research Team

W

Wenbin Shen, MD

CONTACT

J

Jinrui Xu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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