This trial was a single-arm, open-label design to evaluate the efficacy and safety of "TQB2916+ gemcitabine + albumin-paclitaxel" as the first-line treatment for metastatic pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
A Phase II clinical study to evaluate the efficacy and safety of TQB2916 injection combined with gemcitabine and albumin-paclitaxel as first-line treatment for metastatic pancreatic cancer.
Chemotherapy is a systematic treatment.Chemotherapy drugs go into the body orally or intravenously, and they circulate throughout the body, and because of that, they can be used for advanced cancer, and they can also be effective against metastasized cancer cells.There are many chemotherapeutics, but the underlying mechanism is to kill fast growing cells.
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITING6-month progression-free survival rate
The ratio of the time from the start of treatment to 6 months for the subjects to the time from the start of treatment to tumor progression for the subjects.
Time frame: Baseline up to 6 months
objective remission rate
Usually, the proportion of patients whose tumor volume shrinks by 30% is the sum of the proportions of complete response (CR) and partial response (PR).
Time frame: Baseline up to 9 months
Disease Control Rate (DCR)
The proportion of cases that achieved remission (CR+PR) and stable disease (SD) after treatment, that is, the proportion of patients without disease progression (PD).
Time frame: Baseline up to 9 months
Event free survival (EFS) assessed by the investigator
From the time of random initiation to the occurrence of a predetermined event, an event may include death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc.
Time frame: Baseline up to 9 months
Overall survival (OS)
From randomization to the time of death from any cause.
Time frame: Baseline up to 12 months
Duration of Response (DOR)
The period from the first judgment of complete response (CR) or partial response (PR) to the discovery of disease progression (PD).
Time frame: Baseline up to 9 months
Adverse event rate
The occurrence of adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events; The evaluation was conducted based on the standard of CTCAE 5.0.
Time frame: Baseline up to 9 months
The incidence of immunogenicity (ADA)
The incidence of immunogenicity (ADA)
Time frame: Baseline up to 9 months
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