This is a phase II study to evaluate the efficacy and safety of combination of fruquintinib (VEGFR 1/2/3 inhibitor), sintilimab (PD-1 inhibitor) and SOX conversion therapy in unresectable advanced gastric cancer patients.
Eligible patients will be given 3 or 6 cycles of combined therapy of fruquintinib + sintilimab + SOX. Then the patients evaluated resectable will be given one additional cycle of combined treatment with sintilimab + SOX, followed by R0 resection. If evaluated unresectable after 6 cycles of combination therapy, the patient will be given palliative first-line treatment. Adjuvant treatment with SOX regimen will be started 4 weeks after R0 resection for a total of 8 cycles in the perioperative period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
fruquintinib: 4mg/d, qd po, d1-14, q3w; sintilimab: 200 mg/d, IV d1, q3w; S-1: BSA\<1.25 m2, 40mg twice/day; BSA1.25-1.5m2, 50mg twice/day; BSA≥1.5 m2, 60mg twice/day, po, d1-14, q3w; oxaliplatin: 130mg/m2, ivgtt 2-6h, d1, q3w
Henan Tumor Hospital
Zhengzhou, Henan, China
Surgical complete resection rate (R0)
This is a complete macroscopic resection of the gross tumor with negative surgical margins
Time frame: about 3 years
Rate of downstaging
To determine the rate of downstaging of locally advanced cT3-4 and/or N+ gastric carcinomas after preoperative therapy
Time frame: about 3 years
Pathological complete response (pCR) rate
pCR is defined as the absence of residual tumor based on evaluation of the resected esophagogastric specimen according to Becker remission criteria
Time frame: about 3 years
Major pathological response (MPR)
MPR is defined as less than 10% residual tumor after neoadjuvant therapy
Time frame: about 3 years
Objective Response Rate (ORR)
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.
Time frame: about 3 years
Event-free survival (EFS)
Event-free survival (EFS) is defined as the time from treatment initiation until the occurrence of any predefined event, including disease progression preventing planned surgery, local or distant recurrence, or death from any cause.
Time frame: about 3 years
Overall survival (OS)
Overall survival (OS) \[time frame: from the initial date of neoadjuvant therapy to the date of death due to any cause. Patients without documentation of death at the time of analysis will be censored at the last follow-up date\]. Estimated using Kaplan-Meier method.
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Time frame: about 3 years
adverse event (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: about 3 years
R0 Surgical Conversion Rate
R0 Surgical Conversion Rate is defined as the proportion of R0 resections among patients who completed planned conversion therapy and underwent surgical exploration.
Time frame: about 3 years