Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients

Sponsor
Xinqiao Hospital of Chongqing
Study ID
NCT02579564
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
  • Vinorelbine — DRUG
  • Paclitaxel — DRUG
  • Pemetrexed — DRUG
  • Oncorine — DRUG
  • Endostar — DRUG
  • Cisplatin — DRUG

Study Details

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.

Key Dates

Start date
Oct 31, 2016
Status verified
Oct 2016
Primary completion
Jun 30, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: chemotherapy with Oncorine and Endostar
    Systemic chemotherapy with standard schemes, such as GP (Gemcitabine/Cisplatin), NP (Vinorelbine/Cisplatin), TP (Paclitaxel/Cisplatin) or PP (Pemetrexed/Cisplatin). Thoracic cavity perfusion of recombinant human adenovirus type 5 injection 1.5ml and Endostar 30mg each time, twice a week for four times.
  • Active Comparator: chemotherapy with cisplatin
    Systemic chemotherapy with standard schemes without cisplatin, such as Gemcitabine, Vinorelbine, Paclitaxel or Pemetrexed. Thoracic cavity perfusion of cisplatin 30mg/m2 each time, twice a week for four times.

Primary Outcome Measure

Objective response rate (ORR) of malignant pleural effusions [ Time Frame: up to 3 years ]

Central Contacts

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