SODIUM FOLINATE

DRUG4 trials

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, ITM Solucin GmbH, Alligator Bioscience AB, Krankenhaus Nordwest

Conditions

Gastric CancerMetastatic pancreatic ductal adenocarcinomaNeuroendocrine Tumors of GastroEnteric or Pancreatic Origin (GEP-NET)Patients affected by mCRC harbouring BRAF V600ESomatostatin receptor-positive (SSTR+)Well-differentiated Aggressive Grade 2 and Grade 3

Phase 1

An open-label phase 1b/2 study assessing the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma

Active, not recruitingCTIS2024-514905-79-00

Alligator Bioscience ABMetastatic pancreatic ductal adenocarcinoma

Start: 2021-09-17Target: 94Updated: 2025-07-02

Phase 2

ENCORAFENIB+CETUXIMAB BEYOND PROGRESSION IN COMBINATION WITH FOLFIRI IN PATIENTS WITH BRAF V600E MUTATED METASTATIC COLORECTAL CANCER PROGRESSING ON ENCORAFENIB + CETUXIMAB

RecruitingCTIS2023-508615-24-00

Fondazione Policlinico Universitario Agostino Gemelli IRCCSPatients affected by mCRC harbouring BRAF V600E

Start: 2024-06-03Target: 25Updated: 2024-04-04

Phase 3

Chemotherapy Alone vs. Chemotherapy + Surgical Resection in Patients With Limited-metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

CompletedNCT02578368

Krankenhaus NordwestGastric Cancer

Start: 2016-02-29End: 2024-08-27Updated: 2024-11-12

A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor‑positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin

Active, not recruitingCTIS2024-510812-64-00

ITM Solucin GmbHNeuroendocrine Tumors of GastroEnteric or Pancreatic Origin (GEP-NET), Somatostatin receptor-positive (SSTR+), Well-differentiated Aggressive Grade 2 and Grade 3

Start: 2021-09-30Target: 153Updated: 2025-11-12

Related Papers

A phase II study of encorafenib and cetuximab (EC) beyond progression in combination with FOLFIRI in <i>BRAF</i> V600E-mutated metastatic colorectal cancer (mCRC).

Journal of Clinical Oncology2025-05-28

Effect of chemotherapy/targeted therapy alone vs. chemotherapy/targeted therapy followed by radical surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction: The IKF-575/RENAISSANCE phase III trial.

Journal of Clinical Oncology2024-06-0534 citations

Study protocol of an open-label, single arm phase II trial investigating the efficacy, safety and quality of life of neoadjuvant chemotherapy with liposomal irinotecan combined with Oxaliplatin and 5-fluorouracil/Folinic acid followed by curative surgical resection in patients with hepatic Oligometastatic adenocarcinoma of the pancreas (HOLIPANC).

2021-11-1825 citations

Oligometastatic gastric cancer: An emerging clinical entity with distinct therapeutic implications.

2018-11-1014 citations

The RENAISSANCE (AIO-FLOT5) trial: effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction - a phase III trial of the German AIO/CAO-V/CAOGI.

2017-12-28151 citations

The “RENAISSANCE” Trial: Effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction—A phase III trial of the German AIO/CAO-V/CAOGI.

Journal of Clinical Oncology2017-05-202 citations