Browse
Submit Data
Databases
API
Help

Dataset Information

0 Views

0 Connections

0 Citations

0 Reanalyses

0 Downloads

Omics score: 0

Study of the safety and efficacy of donafenib combined with toripalimab in patients with non-MSI-H metastatic colorectal cancer

ABSTRACT: Interventions: experimental group:Donafenib + Toripalimab Primary outcome(s): Objective response rate Study Design: Single arm

DISEASE(S): Colorectal Cancer

PROVIDER: 2717190 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Json Xml

Similar Datasets

Regorafenib Alone or in Combination With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

Project description:The study compares the efficacy and safety of regorafenib alone or in combination with stereotactic ablative radiotherapy (SABR) and low-dose radiotherapy (LDRT) plus toripalimab in patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). Patients are randomly assigned (1:1) into the control arm and the experimental arm. Control arm: a total of 45 patients will receive regorafenib monotherapy. Experimental arm: a total of 45 patients will first receive 1 cycle of regorafenib and toripalimab followed by SABR/LDRT radiotherapy. Regorafenib and toripalimab will be continued after the completion of radiotherapy. The objective response rate (ORR), survival benefits, and adverse effects will be analyzed.

| 67834 | ecrin-mdr-crc

A phase II study to evaluate the safety and efficacy of anlotinib combined with toripalimab for advanced biliary tract cancer.

Project description:ObjectivesTo assess the safety and efficacy of anlotinib (a multi-targeted tyrosine kinase inhibitor) combined with toripalimab (a PD-1 monoclonal antibody) in the treatment of unresectable biliary tract cancer (BTC).MethodsIn this prospective, single-arm, single-centre exploratory clinical study, patients with locally progressed or metastatic BTC were included. Patients were treated with anlotinib (12 mg, PO, QD, for 2 weeks and then stopped for a week, 21 days for a cycle) and toripalimab (240 mg, IV, Q3W). The primary endpoint of the study was the objective response rate (ORR), as defined in RECIST version 1.1 criteria.ResultsIn this study, 15 BTC patients who met the criteria were enrolled. The ORR was 26.7%, the median progression-free survival (mPFS) was 8.6 months (95% CI: 2.1-15.2), the median overall survival (mOS) was 14.53 months (95% CI: 0.8-28.2) and the disease control rate (DCR) was 87.6%. A patient with hilar cholangiocarcinoma was successfully converted after three cycles of treatment and underwent surgical resection. Furthermore, patient gene sequencing revealed that STK11 was mutated more frequently in patients with poor outcomes. In addition, patients with a CD8/Foxp3 ratio > 3 had a longer survival than those with a CD8/Foxp3 ratio ≤ 3 (P = 0.0397).ConclusionsIn patients with advanced BTC, the combination of anlotinib and toripalimab demonstrated remarkable anti-tumor potential, with increased objective response rates (ORR), longer overall survival (OS) and progression-free survival (PFS). Moreover, STK11 and CD8/Foxp3 may be as biomarkers that can predict the effectiveness of targeted therapy in combination with immunotherapy.

| S-EPMC10786709 | biostudies-literature

A prospective, single-arm phase II clinical study of Toripalimab combined with Fruquintinib in the treatment of pMMR /MSS relapsed and refractory advanced colorectal cancer

Project description:Interventions: experimental group:Toripalimab combined with Fruquintinib Primary outcome(s): ORR Study Design: Single arm

| 2689685 | ecrin-mdr-crc

Toripalimab combined with Cetuximab and FOLFIRI for first-line treatment of metastatic unresectable left side, KRAS/NRAS/BRAF wild-type advanced colorectal cancer: a single-arm, open, multicenter clinical study

Project description:Interventions: experimental group:Toripalimab combined with Cetuximab and FOLFIRI Primary outcome(s): ORR Study Design: Single arm

| 2694036 | ecrin-mdr-crc

A LM-302 Combined With Toripalimab Phase II Study

Project description:A Phase II, Open-Label, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of LM-302 Combined With Toripalimab in CLDN18.2 Positive Patients advanced gastro-Intestinal Cancer

| 65674 | ecrin-mdr-crc

Toripalimab Plus Bevacizumab and Chemotherapy as Neoadjuvant Therapy in Advanced MSI-H or dMMR Colorectal Cancer

Project description:This is a trial investigating the efficacy and safety of Toripalimab combined with bevacizumab and chemotherapy as neoadjuvant therapy in patients with advanced microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR) colorectal cancer.

| 2385325 | ecrin-mdr-crc

Clinical study of pembrolizumab combined with DEB-TACE in unresectable MSI-H/dMMR colorectal cancer liver metastasis

Project description:Interventions: Experimental group:Pembrolizumab + DEB-TACE Primary outcome(s): objective response rate Study Design: Single arm

| 37109 | ecrin-mdr-crc

A Safety and Efficacy Study of Concomitant Administration of ChAd63/MVA ME-TRAP + RTS,S

Project description:This clinical trial (NCT02252640) assesses the safety and immune responses to vaccination with experimental malaria vaccine candidates RTS,S/AS01, ChAd63 ME-TRAP and MVA ME-TRAP in different combinations. All healthy volunteers were recruited in England and administered the experimental malaria vaccines. Furthermore, volunteers were infected with malaria by mosquito bites, 12 weeks after the first vaccination to assess vaccine efficacy.

2020-09-01 | GSE103874 | GEO

Efficacy and safety of cetuximab plus FOLFIRI/FOLFOX combined with thalidomide in first-line treatment of RAS and BRAF wild-type stage IV left colorectal cancer

Project description:Interventions: Experimental group:cetuximab plus FOLFIRI/FOLFOX combined with thalidomide Primary outcome(s): Objective response rate, ORR Study Design: Single arm

| 86573 | ecrin-mdr-crc

The reintroduction of cetuximab in combination with toripalimab in RAS/BRAF wild-type advanced colorectal cancer: a phase II clinical study

Project description:Interventions: toripalimab+cetuximab: toripalimab+cetuximab Primary outcome(s): overall survival Study Design: Single arm

| 85617 | ecrin-mdr-crc