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Recruiting Phase 2 NCT06767813

Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms

Trial Parameters

Condition Pancreatic Neoplasms
Sponsor Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-03-19
Completion 2026-11
Interventions
TQB2868 injectionGemcitabine injectionAlbumin paclitaxel injection

Brief Summary

To evaluate the efficacy and safety of TQB2868 injection combined with anlotinib capsule and chemotherapy in treated patients with Pancreatic Neoplasms

Eligibility Criteria

Inclusion Criteria: * Subjects must voluntarily participate in the study and sign the informed consent form. * Aged between 18 and 75 years (inclusive) at the time of signing the informed consent form. * Diagnosed with pancreatic ductal adenocarcinoma through histological or cytological confirmation. * Have at least one evaluable metastatic lesion according to RECIST 1.1 criteria; * No prior systemic anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy). Patients who experience disease progression more than 6 months after completing neoadjuvant or adjuvant therapy are eligible. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of more than 3 months. * Normal major organ function. * Patients must use reliable contraception during the study period and for 6 months after the end of the study period; Female participants must have a negative serum or urine pregnancy test within 7 days p

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