A Real-World Study of Neoadjuvant/Conversion Therapy for Locally Advanced or Metastatic Gastric Cancer
NCT Number: NCT06464601
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer
Interventions: COMBINATION_PRODUCT: fruquintinib combined with immune checkpoint inhibitors and chemotherapy|COMBINATION_PRODUCT: fruquintinib combined with immune checkpoint inhibitors and chemotherapy
Sponsor: Wuhan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-04-01
Completion Date: 2027-03-31
Locations: Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430000, China

Summary:
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.

Primary Outcome Measures: 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 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 from the first treatment up to 24 weeks
Secondary Outcome Measures: Corhot1: R0 resection rate, R0 resection rate: Defined as the proportion of subjects achieving negative margins among those who underwent surgical treatment., 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 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 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., 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 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., 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., 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 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 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., through study completion, an average of 1 year.