Fluorouracil 25 mg/ml Solution for Injection or Infusion

DRUG4 trials

Sponsors

Glaxosmithkline Research & Development Limited, SOTIO Biotech a.s., Institut De Cancerologie De L Ouest, Unicancer

Conditions

Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon CancerPatients with newly diagnosed advanced peritoneal metastasis from colorectal cancerStage III colorectal cancergastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ) and pancreatic adenocarcinoma

Phase 1

A multicentric phase 1/2 trial to evaluate the safety and efficacy of SOT102 as monotherapy and in combination with standard of care treatment in patients with gastric and pancreatic adenocarcinoma

CompletedCTIS2023-504441-31-00

SOTIO Biotech a.s.gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ) and pancreatic adenocarcinoma

Start: 2022-06-29End: 2024-12-13Target: 205Updated: 2024-07-15

Phase 2

Systemic antitumor treatment with or without pressurized intraperitoneal aerosol chemotherapy (PIPAC) for colon peritoneal metastases – a multicentre phase II randomized trial (PIPOX02)

RecruitingCTIS2024-514560-10-00

Institut De Cancerologie De L OuestPatients with newly diagnosed advanced peritoneal metastasis from colorectal cancer

Start: 2025-06-12Target: 114Updated: 2024-10-11

Phase 3

A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy versus Standard of Care in Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Active, not recruitingCTIS2023-503265-27-00

Glaxosmithkline Research & Development LimitedParticipants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Start: 2023-11-23Target: 477Updated: 2025-10-20

CIRCULATE III - Tailoring the decision for adjuvant chemotherapy using circulating tumour DNA, in patients with stage III colorectal cancer

Not yet recruitingCTIS2025-521045-24-00

UnicancerStage III colorectal cancer

Target: 240Updated: 2026-04-28