Status:
NOT_YET_RECRUITING
A Phase lb/lI Clinical Study in Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Rui-hua Xu, MD, PhD
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a prospective, single-arm, open-label，multi-center, phase Ib/II study, aiming to evaluate the efficacy and safety of Fruquintinib combined With Cadonilimab (AK104) and Tegafur，Gimeracil and Ot...
Detailed Description
Esophageal cancer is a malignant tumor with high incidence and death rate in the world, especially in china, and Esophageal squamous cell carcinoma (ESCC) is the main pathological type of esophageal c...
Eligibility Criteria
Inclusion
- age:18-75 years old, Male or female patients
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (including the gastroesophageal junction), (Adenosquamous carcinoma with squamous cell carcinoma components-based is allowed to be included)
- Irretrievably resected, local advanced, relapsed or metastatic esophageal squamous cell carcinoma
- Previously received platinum-based systemic anti-tumor first-line therapy; Or received Neoadjuvant, adjuvant therapy, or radical chemoradiotherapy for ESCC, but disease recurrence or progression within 6 months after completion of treatment; no restrictions on prior immunotherapy treatment choice.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1
- At least one measurable lesion (RECIST1.1)
- Life expectancy of more than 3 months;
- Women of childbearing age were required to have had a negative pregnancy test (serum or urine) within 14 days before enrollment and to voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug.For men, either surgical sterilization or consent to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of the study drug was given
- Have fully understood and voluntarily sign the ICF for this study;
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
- Adequate hepatic, renal, heart, and hematologic functions
Exclusion
- Have had other malignancies within the past 5 years, except for curatively treated radical skin basal cell or squamous cell carcinoma, Or cervical carcinoma in situ;
- Have received major surgical procedures (such as craniotomy, thoracotomy, or laparotomy) within 4 weeks before enrollment or are excepted to uddergo major surgery during the study treatment; received laparoscopic exploration within 2 weeks before enrollment; received central venous catheterization within 7 days prior to enrollment
- Have received chemotherapy, targeted therapy, traditional Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukins, etc.) within the first 4 weeks prior to enrollment, or are still within 5 half-lives of such medications
- Have symptomatic central nervous system metastases (with stable brain metastases confirmed by imageology for more than 3 months were eligible)
- Severe infection ((≥CTCAE grade 2 infection) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications;Baseline chest imaging suggested active pulmonary inflammation with clinically relevant symptoms or signs;the presence of signs and symptoms of infection within 2 weeks before the first dose of the study drug ,or the need for treatment with oral or intravenous antibiotics was excluded if prophylactic antibiotics were used;
- Previous and current presence of interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severely impaired pulmonary function may interfere with the detection and management of suspected drug-related pulmonary toxicity in subjects;Subjects with radiation pneumonitis within 6 months
- Had active pulmonary tuberculosis by medical history or CT examination, or who had a history of active pulmonary tuberculosis within 1 year before enrollment ,or who had a history of active pulmonary tuberculosis more than 1 year before enrollment but had not received regular treatment
- Congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- With thrombotic diseases or receiving anticoagulant drugs;
- Patients at risk of gastrointestinal hemorrhage or obstruction;
- Unable to swallow the experimental drug;
- Patients who have previously experienced immune-related myocarditis, pneumonitis, colitis, hepatitis, nephritis, etc.were judged to be at greater risk for immunotherapy retreatment by the investigator;
- Patients with complications who require long-term use of immunosuppressive drugs or those who need systemic or local administration of corticosteroids with immunosuppressive effects
- Patients considered unsuitable for inclusion in this study by the investigator
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06487702
Start Date
July 10 2024
End Date
June 10 2027
Last Update
July 5 2024
Active Locations (1)
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1
Medical Oncology,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060