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Phase II Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab as Third-line Therapy for Colorectal Cancer

ABSTRACT: This study is a single center, investigator initiated phase II clinical study to evaluate the efficacy and safety of fruquintinib plus Sintilimab as third-line therapy for colorectal cancer

DISEASE(S): Metastasis Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2323156 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Neoadjuvant sintilimab plus chemotherapy in early-stage EGFR-mutant NSCLC: phase 2 trial interim results (NEOTIDE/CTONG2104)

Project description:We launched an investigator-initiated, Simon’s two-stage design trial of neoadjuvant sintilimab combined with carboplatin and nab-paclitaxel (nab-PC) in early-stage EGFR-mutant NSCLC (Clinicaltrial.gov number NCT05244213). Here we report the first interim results of stage 1 cohort which met the overall primary endpoint in advance, and multi-omics profiling of neoadjuvant immunotherapy combination in early-stage EGFR-mutant patients. We performed in-depth single-cell RNA/TCR sequencing (scRNA/TCR-seq) of cells derived from 11 resected tumors as well as 34 tumors from real-world cohort which were all confirmed wild-type lung adenocarcinoma (LUAD) or adeno-squamous carcinoma (ASC) and received neoadjuvant immunochemotherapy as control. By associating the tumor microenvironment (TME) and with responses, we uncovered heterogeneous mechanisms of primary resistance, providing insights into further strategic developments of combination regimens to improve the clinical outcome of EGFR-mutant NSCLC patients.

2024-05-17 | GSE241934 | GEO

Radiotherapy in Combination With Sintilimab，GM-CSF and Fruquintinib in Patients With MSS mCRC

Project description:To evaluate the clinical efficacy and safety of hypofractionation radiotherapy combined with sintilimab，GM-CSF and Fruquintinib in Patients With MSS Metastatic Colorectal Carcinoma (mCRC)

| 2710363 | ecrin-mdr-crc

Fruquintinib Combined With Chemotherapy as Third-line /Third-line+ Treatment in Advanced Colorectal Cancer

Project description:To explore the efficacy and safety of fruquintinib combined with chemotherapy as third-line/third-line+ Treatment in advanced metastatic colorectal cancer

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Single-cell RNA sequencing of immune landscape in hepatocellular carcinoma treated with sintilimab and sorafenib

Project description:Checkpoint inhibitors combined with sorafenib for hepatocellular carcinoma (HCC) treatment have achieved satisfactory results in many clinical trials. Understanding the mechanism underlying this modality may provide better strategies to eradicate HCC. In the present study, peripheral blood mononuclear cells (PBMCs) from patients who received combination sintilimab and sorafenib treatment were analyzed by single-cell RNA sequencing (scRNA-seq).

2022-10-17 | GSE215428 | GEO

KEEP-G06A prospective, open, single-center, single-arm phase II study of Sintilimab combined with Fruquintinib and Fecal Microbiota Transplantation(FMT) in the treatment of Non-MSI-H/dMMR advanced colorectal cancer

Project description:Interventions: experimental group:Sintilimab combined with Fruquintinib and Fecal Microbiota Transplantation(FMT) Primary outcome(s): ORR Study Design: Single arm

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TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer

Project description:This is a single-arm, multicentre real-world observational study of TAS-102 in combination with regorafenib or fruquintinib for third-line and above advanced colorectal cancer.

| 69888 | ecrin-mdr-crc

Microsatellite stable metastatic colorectal cancer without liver metastasis may be preferred population for regorafenib or fruquintinib plus sintilimab as third-line or above therapy:A real-world study.

Project description:ObjectivesThe antitumor activity of nivolumab plus regorafenib in colorectal cancer from a phase Ib REGONIVO study is encouraging. The present study was conducted to evaluate the efficacy and safety of regorafenib or fruquintinib plus sintilimab as third-line or above therapy in patients with microsatellite stable (MSS) metastatic colorectal cancer.MethodsPatients with MSS metastatic colorectal cancer who have failed from prior treatment and received regorafenib or fruquintinib plus sintilimab as third-line or above therapy from January 2019 to December 2020 were prospectively analyzed based on real-world clinical practice. The primary end point was progression free survival (PFS). Secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.Results42 patients received regorafenib plus sintilimab(RS), and the other 30 patients received fruquintinib plus sintilimab(FS). In the general population, the ORR and DCR were 13.9% and 70.8%, and the median PFS and OS was 4.2(95% CI=2.9-5.5) and 10.5 (95% CI=8.6-12.4) months, respectively. There were no statistically significant differences between RS and FS group in PFS (3.5(2.2-4.8) vs. 5.5(3.5-7.5) months, P=0.434) and OS (11.0(7.0-15.0) vs. 10.5(3.8-17.2) months, P=0.486). Subgroup analysis suggested that patients without liver metastasis responded well to this combination regimen (ORR: 21.4% vs. 9.1%) and obtained better OS (26(8.8-43.2) vs. 10.0(7.4-12.6) months, P=0.016). The incidence of Grade 3-4 adverse events (AEs) was 15.3% and the toxicities were generally tolerable and manageable.ConclusionsRegorafenib or fruquintinib plus sintilimab as third-line or above therapy provide a feasible treatment regimen for MSS metastatic colorectal cancer with tolerated toxicity. Patients without liver metastasis may be the preferred population for this combination regimen.

| S-EPMC9549285 | biostudies-literature

SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC

Project description:The study is a phase II clinical study. The purpose of the study is to evaluate the efficacy and safety of SBRT combined with Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC.

| 9849 | ecrin-mdr-crc

Hepatic Arterial Infusion Chemotherapy With Fruquintinib for Colorectal Cancer Liver Metastases As Third-line Therapy

Project description:Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. Combined with hepatic arterial infusion chemotherapy (HAIC), this study is conducted to assess the efficacy and safety of this regimen in patients with unresectable colorectal cancer liver metastases as the third-line therapy.

| 2733287 | ecrin-mdr-crc

Efficacy of sintilimab and fruquintinib combination treatment in the management of microsatellite-stable metastatic colorectal cancer: a case report.

Project description:BackgroundThe immune microenvironment of deficient mismatch repair or microsatellite instability-high (dMMR/MSI-H) colorectal cancer exhibits better immune activity, and patients with dMMR/MSI-H colorectal cancer benefit from immunotherapy with programmed death-1 (PD-1)/PD-1 ligand (PD-L1) inhibitors and cytotoxic T-lymphocyte associated protein 4 (CTLA-4) inhibitors as a first-line treatment. However, for microsatellite-stable (MSS) colorectal cancer, which accounts for the majority of the cases of colorectal cancer, immunotherapy has yielded little success, especially in cases of patients with advanced colorectal cancer in whom multiple lines of chemotherapy have failed. Hence, safe and effective targeted treatment strategies are urgently needed to achieve greater survival benefits.Case descriptionWe report a case in which next-generation sequencing (NGS) and immunohistochemistry (IHC) showed that that the patient's molecular characteristics were as follows: MSS, low expression of PD-L1, and high tumor mutation burden (TMB-H). Due to the failure of multiple lines of chemotherapy and severe chemotherapeutic adverse effects, a combined targeted immunotherapy regimen was utilized. After 6 months of treatment, imaging suggested near-complete clinical remission, and at the 18-month follow-up, the patient had a good quality of life and imaging showed no tumor recurrence.ConclusionsThis case suggests that a good response to a combined targeted immunotherapy regimen can be achieved in patients with MSS metastatic colorectal cancer, in addition, it also suggests that TMB-H is a predictive biomarker for clinical benefit from immunotherapy in MSS metastatic colorectal cancer.

| S-EPMC9011267 | biostudies-literature

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