A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • TQB2916 Injection
  • Chemotherapy

Treatment groups

50 Participants
are divided into 1 treatment group