NCT02579564

Systemic Chemotherapy Combined With Thoracic Cavity Perfusion of Recombinant Human Adenovirus Type 5 and Endostatin Injections Versus Cisplatin for Treatment Malignant Hydrothorax in Non Small Cell Lung Cancer (NSCLC) Patients: A Multi-center, Randomized, Controlled Clinical Trial

Status unknown Phase 3 Last updated 20 October 2016

What this trial tests

Phase 3 trial testing Gemcitabine in Malignant Hydrothorax in 134 participants. Status unknown.

Timeline

1 October 2016

Primary endpoint
1 June 2018

1 December 2018

Quick facts

Lead sponsor	Xinqiao Hospital of Chongqing
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	134
Start date	1 October 2016
Primary completion	1 June 2018
Estimated completion	1 December 2018

Drugs / interventions tested

• Gemcitabine
• Vinorelbine
• Paclitaxel — full drug profile →
• Pemetrexed — full drug profile →
• Oncorine — full drug profile →
• Endostar
• Cisplatin (cisplatin) — full drug profile →

Conditions studied

• Malignant Hydrothorax — all drugs for Malignant Hydrothorax →
• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →

Sponsor

Xinqiao Hospital of Chongqing

Who can join

Adults 18 to 75, any sex, with Malignant Hydrothorax or Non Small Cell Lung 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.

• Objective response rate (ORR) of malignant pleural effusions
  Time frame: up to 3 years
  Assessed by WHO Cancerous effusion scoring system

Sponsor's own description

The purpose of this multi-center clinical trial is to verify more effective on local control of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar) compared with cisplatin perfusion, with acceptable side effects.

Publications & conference data

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

1. Development and Clinical Translation of Approved Gene Therapy Products for Genetic Disorders.
   Shahryari A, Saghaeian Jazi M, Mohammadi S, Razavi Nikoo H, et al · · 2019 · cited 168× · PMID 31608113 · DOI 10.3389/fgene.2019.00868
2. The emerging role of oncolytic virus therapy against cancer.
   Russell L, Peng KW. · · 2018 · cited 106× · PMID 29764161 · DOI 10.21037/cco.2018.04.04
3. Concepts in Oncolytic Adenovirus Therapy.
   Mantwill K, Klein FG, Wang D, Hindupur SV, et al · · 2021 · cited 75× · PMID 34638863 · DOI 10.3390/ijms221910522
4. Advances in the clinical development of oncolytic viruses.
   Li K, Zhao Y, Hu X, Jiao J, et al · · 2022 · cited 33× · PMID 35836877
5. Developing Picornaviruses for Cancer Therapy.
   McCarthy C, Jayawardena N, Burga LN, Bostina M. · · 2019 · cited 31× · PMID 31100962 · DOI 10.3390/cancers11050685
6. Virus-Receptor Interactions and Virus Neutralization: Insights for Oncolytic Virus Development.
   Jayawardena N, Poirier JT, Burga LN, Bostina M. · · 2020 · cited 29× · PMID 32185149 · DOI 10.2147/ov.s186337