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 Cance

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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;

• Without any systematic anti-tumor treatment;

• The Eastern Cooperative Oncology Group (ECOG) score is 0-1, and the expected survival period is more than 3 months;

• The main organs function well;

• Patients must adopt reliable contraceptive measures during the study period and within 6 months after the end of the study period;The serum pregnancy test must be negative within 7 days before enrollment in the study, and the subjects must be non-lactating.

Locations
Other Locations
China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Yi Ba, Doctor
Bayi@tjmuch.com
13752157916
Time Frame
Start Date: 2025-04-18
Estimated Completion Date: 2027-10
Participants
Target number of participants: 50
Treatments
Experimental: TQB2916 Injection +Chemotherapy
TQB2916 injection combined with Chemotherapy, 28 days as a treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov