The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone.
In this prospective, multi-center clinical trial titled "INTENSIFY," we seek to evaluate the potential benefits of integrating Serplulimab and Bevacizumab with the standard FOLFOX chemotherapy regimen as neoadjuvant treatment for surgically resectable colorectal cancer liver metastases (CRLM). Colorectal cancer remains a leading cause of global cancer-related morbidity and mortality, with liver metastases accounting for a significant proportion. Our primary objective is to investigate whether the addition of Serplulimab, a PD-1 inhibitor, and Bevacizumab, an anti-angiogenesis agent, can improve the postoperative prognosis for patients with RAS/BRAF wild-type, pMMR/MSS CRLM. We aim to address critical questions regarding the efficacy of this combined treatment in enhancing the immune microenvironment within the liver, ultimately leading to increased T lymphocyte infiltration and improved patient outcomes. The study will involve a randomized assignment of patients to either the standard FOLFOX chemotherapy arm or the experimental arm receiving FOLFOX in combination with Serplulimab and Bevacizumab. Participants will undergo neoadjuvant treatment, surgical resection, and regular follow-up assessments to evaluate treatment response, recurrence rates, and overall survival. By comparing outcomes between the two groups, specifically assessing factors like recurrence-free survival, overall survival, and changes in the immune microenvironment, we aim to provide valuable insights into the optimization of treatment strategies for this specific subset of colorectal cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
5 mg/m2 IV on day 1
400 mg/m2 IV bolus on day 1, followed by 2.4 g/m2 continuous IV infusion over 48 hours
200 mg IV infusion on day 1
5 mg/kg IV infusion on day 1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITING3-year Progression-Free Survival Rate
The proportion of patients who, following the initiation of treatment, remain both alive and without evidence of disease progression for a consecutive period of three years.
Time frame: Assessed for three years following the initiation of treatment
Median Overall Survival
The duration of time from diagnosis until death
Time frame: Assessed throughout the study duration (5 years)
Major Pathological Response (MPR)
Defined as residual viable tumor of less than or equal to 10%
Time frame: Assessed following neoadjuvant treatment and resection of CRLM (up to 5 years)
Pathologic complete response (pCR)
The absence of tumor cells in all specimens.
Time frame: Assessed following neoadjuvant treatment and resection of CRLM (up to 5 years)
Pathological Partial Response
Defined as residual viable tumor of more than 10% but less than 50%
Time frame: Assessed following neoadjuvant treatment and resection of CRLM (up to 5 years)
Disease Free Survival
The measure of time after treatment during which no sign of cancer is found
Time frame: Assessed throughout the study duration (5 years)
Treatment-related adverse events
Assessment of adverse events related to the treatment received in both arms
Time frame: Assessed throughout the study duration (5 years)
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