NCT03093129: NeoART-V

Phase II Randomised, Double Blind, Placebo Controlled Trial of Neoadjuvant Artesunate in Stage II/III Colorectal Cancer in Vietnamese Patients

Status unknown Phase 2 Last updated 8 January 2018

What this trial tests

Phase 2 trial testing artesunate in Colorectal Cancer in 200 participants. Status unknown.

Timeline

8 January 2018

Primary endpoint
1 December 2021

1 December 2022

Quick facts

Lead sponsor	The 108 Military Central Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	200
Start date	8 January 2018
Primary completion	1 December 2021
Estimated completion	1 December 2022
Sites	1 location across Vietnam

Drugs / interventions tested

• artesunate (ARTESUNATE) — full drug profile →
• placebo

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

The 108 Military Central Hospital

Who can join

Adults 18 to 70, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• recurrence free survival 2 years after surgery
  Time frame: 2 years
  The primary outcome measure for the comparison of the artesunate versus placebo group is recurrence free survival 2 years after surgery

Sponsor's own description

This is a Phase II randomized, double-blind, placebo-controlled trial of neoadjuvant artesunate given orally as a dose of 200 mg once a day for 14 days to patients with histologically confirmed Stage II/III colorectal cancer (CRC) awaiting surgical treatment with curative intent.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ferroptosis in cancer: From molecular mechanisms to therapeutic strategies.
   Zhou Q, Meng Y, Li D, Yao L, et al · · 2024 · cited 439× · PMID 38453898 · DOI 10.1038/s41392-024-01769-5
2. Plant-Derived Anticancer Compounds as New Perspectives in Drug Discovery and Alternative Therapy.
   Dehelean CA, Marcovici I, Soica C, Mioc M, et al · · 2021 · cited 244× · PMID 33669817 · DOI 10.3390/molecules26041109
3. Mitochondria-associated programmed cell death as a therapeutic target for age-related disease.
   Nguyen TT, Wei S, Nguyen TH, Jo Y, et al · · 2023 · cited 221× · PMID 37612409 · DOI 10.1038/s12276-023-01046-5
4. DHA exhibits synergistic therapeutic efficacy with cisplatin to induce ferroptosis in pancreatic ductal adenocarcinoma via modulation of iron metabolism.
   Du J, Wang X, Li Y, Ren X, et al · · 2021 · cited 149× · PMID 34262021 · DOI 10.1038/s41419-021-03996-y
5. Therapeutic Potential of Certain Terpenoids as Anticancer Agents: A Scoping Review.
   Kamran S, Sinniah A, Abdulghani MAM, Alshawsh MA. · · 2022 · cited 106× · PMID 35267408 · DOI 10.3390/cancers14051100
6. Ferroptosis-modulating small molecules for targeting drug-resistant cancer: Challenges and opportunities in manipulating redox signaling.
   Koeberle SC, Kipp AP, Stuppner H, Koeberle A. · · 2023 · cited 74× · PMID 36658724 · DOI 10.1002/med.21933
7. New drugs are not enough‑drug repositioning in oncology: An update.
   Armando RG, Mengual Gómez DL, Gomez DE. · · 2020 · cited 72× · PMID 32124955 · DOI 10.3892/ijo.2020.4966
8. Anti-Inflammatory and Immunoregulatory Action of Sesquiterpene Lactones.
   Paço A, Brás T, Santos JO, Sampaio P, et al · · 2022 · cited 70× · PMID 35164406 · DOI 10.3390/molecules27031142