A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 in treating Patients with Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer combined with Systemic Therapy.
The phase II study is a controlled, open-label trial designed to assess the effectiveness and safety of M701 intra-peritoneal infusion for controlling malignant ascites in patients with gastrointestinal and ovarian cancer who are also receiving systemic therapy. A total of 80 patients with malignant ascites caused by gastrointestinal or ovarian cancer will be randomly assigned to two treatment arms in a 1:1 ratio. These patients must have experienced disease progression or intolerance after receiving at least two lines of systemic therapy. Both treatment arms will receive the systemic therapy, but the test arm will additionally receive M701 intra-peritoneal infusion, while the control arm will undergo paracentesis only. The primary endpoint of the study will be the puncture-free survival, which evaluates the efficacy of M701 in controlling malignant ascites. Secondary endpoints include the objective response rate (ORR) of malignant ascites, progression-free survival (PFS), overall survival (OS), quality of life (QOL), and safety profiles. The number of EpCAM-positive cells in the malignant ascites will be measured using flow cytometry before and after treatment with M701.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Intra-peritoneal infusion of M701 combined with system therapy
paracentesis combined with system therapy
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Puncture-free survival, PuFS
The time to the next puncture/drainage or death
Time frame: From the time of 4th dosing (Day 18) to the next puncture/drainage or death (up to 6 months)
objective response rate (ORR) of malignant ascites
The change of precentage of malignant ascites volume from the baseline by the image evaluation
Time frame: From the time of 4th dosing (Day 18) to the next puncture/drainage or death (up to 180 days)re/drainage or death (up to 6 months)
Progression-free Survival, PFS
The time to disease progression assessed by the imaging evaluation or toxicity or death
Time frame: From the time of first dosing (Day 1) until disease progression or toxicity intolerance or death (up to 6 months).
Overall survival, OS
The time to death
Time frame: From the time of first dosing (Day 1) until death (up to 6 months).
Quality of Life, QoL
Using the QLQ-C30 Scale to score the quality of life at every visit, which includes 3 parts: global health status(2-14, higher is better), funtional status(16-64, lower is better), symptom scale(12-48, lower is better),
Time frame: From the time of first dosing (Day 1) until the EOT (up to 6 months).
Safety profiles
frequency, relationship and seriousness of adverse events
Time frame: From the time of first dosing (Day 1) until one month after the EOT (up to 6 months).
Positive rate of ADA and Nab in serum
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The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab) in the serum during the study
Time frame: From the time of first dosing (Day 1) until the EOT (up to 6 months).
The EpCAM expression in ascites
Measure the count of EpCAM postive cells in the ascites before and after M701 treatment
Time frame: From the time of first dosing (Day 1) until the EOT (up to 6 months).
Trough serum concentration (Ctrough)
The lowest concentration of M701 in the serum in one treatment cycle
Time frame: 6 months (anticipated)
Peak serum concentration (Cmax)
The highest concentration of M701 in the serum in one treatment cycle
Time frame: 6 months (anticipated)