Chemotherapy, immune checkpoint inhibitors, and anti-angiogenic targeted therapies have been explored in combination for neoadjuvant and conversion therapies. However, the efficacy of the novel anti-angiogenic agent fruquintinib in combination with immune checkpoint inhibitors and chemotherapy in the neoadjuvant and conversion treatment of locally advanced or metastatic gastric cancer has not been reported. This study aims to observe the efficacy and safety of fruquintinib combined with immune checkpoint inhibitors and chemotherapy in real-world settings.
Study Type
OBSERVATIONAL
Enrollment
70
Chemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: XELOX or SOX. Immune Checkpoint Inhibitors: Selection based on clinical guidelines/indications and patient condition, including but not limited to PD-1 inhibitors, PD-L1 inhibitors. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.
Chemotherapy Drugs: Selection based on clinical guidelines/indications and patient condition.For example, recommended chemotherapy regimens: XELOX or SOX. Immune Checkpoint Inhibitors: Selection based on clinical guidelines/indications and patient condition, including but not limited to PD-1 inhibitors, PD-L1 inhibitors. Fruquintinib: 3mg (starting dose), PO (once daily). Dosing schedule and dosage can be adjusted based on concurrent chemotherapy and immune checkpoint inhibitors. Have received fruquintinib treatment for at least 2 cycles.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Corhot1: Pathological Complete Response Rate (pCR)
Pathological Complete Response Rate (pCR), defined as no residual tumor cells in the surgical specimen of the primary tumor and lymph nodes (ypT0N0); corresponds to TRG grade 0.
Time frame: Time from the first treatment up to 12 weeks
Corhot2: R0 surgical conversion rate
R0 surgical conversion rate:The proportion of subjects who achieve complete R0 resection of both the primary gastric lesion and any metastases among all subjects receiving the conversion therapy regimen.
Time frame: Time from the first treatment up to 24 weeks
Corhot1: R0 resection rate
R0 resection rate: Defined as the proportion of subjects achieving negative margins among those who underwent surgical treatment.
Time frame: Time from the first treatment up to 12 weeks
Corhot1: Event-Free Survival (EFS)
Event-Free Survival (EFS): Time from initiation of neoadjuvant study treatment until first documented progression, recurrence/metastasis, or death from any cause (whichever occurs first, without progression/recurrence at the time of death).
Time frame: Time from the first treatment up to 2 years.
Corhot1: 1-year Event-Free Survival (EFS) rate
1-year Event-Free Survival rate: Survival rate of patients who, from initiation of neoadjuvant study treatment, have not experienced progression, recurrence/metastasis, or death from any cause at 12 months.
Time frame: Time from the first treatment up to 12 months.
Corhot1 and Corhot2: Overall Survival (OS)
Overall Survival (OS): Time from the first study treatment until death from any cause.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Time from the first treatment up to 2 years.
Corhot1 and Corhot2: 1-year Overall Survival (OS) rate
1-year OS rate: Survival rate of patients who have not experienced progression or death from any cause at 12 months from the first study treatment.
Time frame: Time from the first treatment up to 12 months.
Corhot1 and Corhot2: Objective Response Rate (ORR)
Objective Response Rate (ORR): Proportion of patients with target lesions who achieve a complete response (CR) or partial response (PR) among all treated patients.
Time frame: corhot1 :Time from the first treatment up to 12 weeks. Corhot2:Time from the first treatment up to 2 years.
Corhot1 and Corhot2: Disease Control Rate (DCR)
Disease Control Rate (DCR): Proportion of patients with target lesions who achieve a complete response (CR), partial response (PR), or stable disease (SD) among all treated patients.
Time frame: corhot1 :Time from the first treatment up to 12 weeks. Corhot2:Time from the first treatment up to 2 years.
Corhot2: Curative Surgery Conversion Rate
Curative Surgery Conversion Rate: The proportion of subjects who undergo potentially curative surgical resection of both the primary gastric lesion and any metastases among all subjects receiving the conversion therapy regimen.
Time frame: Time from the first treatment up to 24 weeks
Corhot2: Progression-Free Survival (PFS)
Progression-Free Survival (PFS): Defined as the time from initiation of the study treatment regimen until the first radiographic disease progression, postoperative disease recurrence, or death (whichever occurs first). This can be calculated separately for surgical and non-surgical patients, with surgical patients considering postoperative disease recurrence or death (whichever occurs first).
Time frame: Time from the first treatment up to 2 years.
Corhot1and Corhot2: Adverse events
Adverse events during neoadjuvant or conversion therapy, impact on surgery (delay, surgical complications) for corhot1, impact on surgical procedure and postoperative outcomes for corhot2.
Time frame: through study completion, an average of 1 year.