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.
The subjects voluntarily joined this study and signed the informed consent form;
Age: 18-75 years old (the time of signing the informed consent form, including the critical value);
Pancreatic ductal adenocarcinoma confirmed by tissue or cytology (excluding other mixed pancreatic cancers);
Have at least one measurable lesion according to the RECIST 1.1 standard;
Within 5 years, the subject has had or simultaneously suffered from other malignant tumors (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);Patients with other malignant tumors, but the following two situations can be enrolled: other malignant tumors treated by single surgery, achieving R0 resection and no recurrence or metastasis within 5 years;Cured cervical carcinoma in situ, cutaneous basal cell carcinoma, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor-infiltrating basement membrane)];
Unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 caused by any previous treatment, excluding alopecia;
Have received major surgical treatment, obvious traumatic injury, or have long-term unhealed wounds or fractures within 28 days before the first medication;
Patients who experienced any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first administration;
Single group
TQB2916 Injection
DrugA 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
DrugChemotherapy 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.
6-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.
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).
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).
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.
Overall survival (OS)
From randomization to the time of death from any cause.
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