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A single-arm, prospective, exploratory clinical study of surufatinib combined with sintilimab in advanced colorectal cancer

ABSTRACT: Interventions: Group 1 :surufatinib + sintilimab Primary outcome(s): Progression free survival Study Design: Single arm

DISEASE(S): Colorectal Cancer

PROVIDER: 79369 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Surufatinib Combined With Sintilimab for Advanced MSS-Type Colorectal Cancer : a Phase II Study

Project description:A phase II study to assess the efficacy and safety of Surufatinib combined with Sintilimab as a second-line treatment in patients with advanced MSS-Type CRC.

| 2368098 | ecrin-mdr-crc

Surufatinib increases cholangiocarcinoma cells radiosensitivity by anti-tumor proliferation and inhibition of macrophage M2 polarization

Project description:This study confirmed the radiosensitizing effects of surufatinib on cholangiocarcinoma. The mechanism is that surufatinib can activate TLR3, up-regulate the expression of TRIF protein, increase DNA damage and apoptosis after radiation, and up-regulate NF- κB signal pathway to inhibit M2 polarization of tumor-associated macrophages, thus enhance radiosensitivity.

2024-06-30 | GSE269494 | GEO

A single-arm, prospective, Phase II clinical study of surufatinib in combination with tislelizumab in advanced colorectal cancer after third-line treatment failure

Project description:Interventions: Test group:Surufatinib+tislelizumab Primary outcome(s): Progression-free survival Study Design: Single arm

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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

| 36777 | ecrin-mdr-crc

Surufatinib plus toripalimab in patients with advanced solid tumors: a single-arm, open-label, phase 1 trial.

Project description:PurposeThis phase 1 trial evaluated the safety, preliminary efficacy, and pharmacokinetics of surufatinib, a small molecular tyrosine kinase inhibitor, combined with toripalimab, a programmed cell death protein-1 antibody, in patients with advanced solid tumors.MethodsThis is an open-label, dose-escalation and expansion study in patients with solid tumors who had failed standard therapies or had no effective treatment. In the dose-escalation stage, patients were treated with surufatinib, at dose levels of 200, 250, or 300 mg once daily (QD) in combination with toripalimab 240 mg, every 3 weeks (Q3W), to estimate maximum tolerated dose. Additional patients were enrolled in the dose expansion stage to further assess the efficacy, safety, and pharmacokinetics profile. Recommended phase 2 dose (RP2D) was determined based on the safety, tolerability, and preliminary efficacy from dose-escalation and expansion stages.ResultsFrom Feb 14, 2019 to Dec 20, 2020, 33 patients were screened, of which 30 patients were enrolled. One patient in the 300 mg cohort experienced dose limited toxicity, a grade 3 hyperthyroidism. The most frequent treatment-related adverse events of grade ≥ 3 were hypertension (20.0%), transaminases increased (13.3%), and blood bilirubin increased (13.3%). No treatment-related death or treatment discontinuation was identified. The RP2D was determined to be surufatinib 250 mg QD plus toripalimab 240 mg Q3W. Objective response rate was 24.1% (95% confidence interval 10.3‒43.5%) in this study.ConclusionsSurufatinib plus toripalimab was well tolerated, with no unexpected safety signals, and showed preliminary anti-tumor activity in patients with advanced solid tumors.Trial registrationClinicaltrials.gov Identifier: NCT03879057; registration date: March 18, 2019.

| S-EPMC9931771 | biostudies-literature

A single arm, phase II study for Sintilimab for injection combined with Regorafenib tablets in the third or more line treatment of advanced colorectal cancer

Project description:Interventions: Experimental group:Sintilimab and Regorafenib Primary outcome(s): ORR (Objective Response Rate) Study Design: Single arm

| 2739606 | ecrin-mdr-crc

Second-line Surufatinib Combined With Chemotherapy in Advanced CRC

Project description:A phase II, muti-cohort study to assess the efficacy and safety of Surufatinib combined with chemotherapy as a second-line treatment in patients with advanced CRC

| 2365809 | ecrin-mdr-crc

Efficacy and Safety of Sintilimab Plus Anlotinib for PD-L1-Positive Recurrent or Metastatic Cervical Cancer: A Multicenter, Single-Arm, Prospective Phase II Trial.

Project description:PurposeNo combined immunotherapy and antiangiogenic therapy have been investigated in exclusively programmed death-ligand 1 (PD-L1)-positive advanced cervical cancer (CA). We investigated the efficacy and safety of sintilimab plus anlotinib as second-line or later therapy for PD-L1-positive recurrent or metastatic (R/M) CA.Patients and methodsPatients with PD-L1-positive (Combined Positive Score ≥ 1) R/M CA who progressed after at least one prior systemic chemotherapeutic regimen or could not tolerate chemotherapy were eligible for the phase II trial. The patients received 200 mg sintilimab once on day 1 and 10 mg anlotinib once daily on days 1-14 every 3 weeks. The primary end point was investigator-confirmed objective response rate (ORR) per RECIST v1.1. Secondary end points included progression-free survival (PFS), overall survival, and disease control rate. Biomarkers were explored.ResultsForty-two patients were enrolled. The ORR was 54.8% (95% CI, 38.7 to 70.2). In 39 efficacy-evaluable patients, the ORR was 59.0% (95% CI, 42.1 to 74.4); the disease control rate was 94.9% (95% CI, 82.7 to 99.4). The median PFS was 9.4 months (95% CI, 8.0 to 14.6). The median overall survival was not reached. Furthermore, 85.8% of the patients experienced treatment-related adverse events. The most frequent treatment-related adverse events were hypothyroidism (33.3%), elevated aspartate aminotransferase levels (21.4%), and hypertension (19.0%). Patients with altered PIK3CA, PI3K-AKT signaling, or KMT2D had a higher ORR, whereas those with altered STK11 and/or JAK2 had a significantly shorter PFS.ConclusionSintilimab plus anlotinib as second-line or later therapy is efficacious and safe for patients with advanced CA who have failed prior chemotherapy.

| S-EPMC9148684 | biostudies-literature

Sintilimab Plus Apatinib and Chemotherapy as Second‑/Third-Line treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a prospective, Single-Arm, phase II trial.

Project description:BackgroundThe prognosis of patients with previously treated advanced gastric or gastroesophageal junction (GEJ) cancer remains poor. Given the robust development of immunotherapy and targeted therapy during the last decades, we aimed to investigate if the combination of traditional second-line chemotherapy with sintilimab and apatinib could bring survival benefits for these patients.MethodsIn this single-center, single-arm, phase II trial, patients with previously treated advanced gastric or GEJ adenocarcinoma received specific dose level of intravenous paclitaxel or irinotecan (investigator's choice), 200 mg intravenous sintilimab on day 1, and 250 mg oral apatinib once daily continuously in each cycle until disease progression, intolerable toxicity, or withdrawal of consent. The primary endpoints were objective response rate and progression-free survival. The secondary endpoints were mainly overall survival and safety.ResultsFrom May 2019 to May 2021, 30 patients were enrolled. At the data cutoff date (March 19, 2022), the median follow-up duration was 12.3 months and 53.6% (95% CI, 33.9-72.5%) patients achieved objective response. The median progression-free survival and overall survival were 8.5 months (95% CI, 5.4-11.5) and 12.5 months (95% CI, 3.7-21.3), respectively. Grade 3-4 adverse events included hematological toxicities, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated alkaline phosphatase, elevated gamma-glutamyl transpeptidase, hyperbilirubinemia and proteinuria. The most frequent grade 3-4 adverse event was neutropenia (13.3%). No serious treatment-related adverse events or treatment-related deaths occurred.ConclusionSintilimab plus apatinib and chemotherapy demonstrates promising anti-tumor activity with manageable safety profile in patients with previously treated advanced gastric or GEJ cancer.Trial registrationClinicalTrials.gov: NCT05025033, 27/08/2021.

| S-EPMC9985926 | biostudies-literature

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