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 Oteracil Potassium in patients with locally advanced or metastatic esophageal squamous cell carcinoma after the failure of first-line treatments.
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.
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)
Single group
fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil Potassium
DrugFruquintinib administration for 2 weeks followed by 1-week break Candonilimab：10 mg/kg，D1，Q3W； Tegafur，Gimeracil and Oteracil Potassium：30mg BID for body surface area \< 1.25 m2; 40mg BID for body surface area of 1.25-1.5 m2; and 50mg BID for body surface area \>1.5 m2; D1-14, q3w
MTD and/or PR2D
To determine the Maximum Tolerated Dose ( MTD) and/or PR2D of fruquintinib combined with Cadonilimab and Tegafur,Gimeracil and Oteracil Porassium in patients with Esophageal squamous cell carcinoma (Phase Ib)
16-Week Progression-free Survival (PFS) Rate (Phase II)
16-Week Progression-free survival (PFS) rate is defined as the percentage of patients who are progression-free (stable disease, partial response, or complete response as defined by RECIST v1.1 criteria) at 16 weeks post registration
Overall Response Rate (ORR) (Phase Ib）
from treatment up to progressive disease or EOT due to any cause up to 1 year
Disease control rate (DCR) (Phase Ib）
Tumor assessment will be performed using radiography method every 6 weeks until the occurrence of progressive disease (PD), using RECIST v 1.1
Overall survival (OS) （Phase Ib)
Baseline to measured date of death from any cause
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Rui-hua Xu, MD, PhD
Lead sponsor
Sun Yat-sen University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
