This study adopts a randomized, open label, placebo-controlled, multicenter trial design. OS was the primary endpoint, and eligible subjects were randomly divided into 1:1 groups and received TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy, compared to placebo combined with chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
566
TQB2868 injection: PD-L1 and Transforming Growth Factor-beta (TGF - β) dual antibody
Anlotinib Hydrochloride Capsules
Gemcitabine Hydrochloride Injection
Paclitaxel for Injection
TQB2868 Placebo without drug substance
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGAnhui Provincial Cancer Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Overall Survival
By evaluating overall survival (OS), this study aims to demonstrate the efficacy of TQB2868 injection combined with anlotinib hydrochloride capsules in chemotherapy compared to placebo combined with chemotherapy in the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC).
Time frame: The duration is approximately 2 years
Progression-Free Survival evaluated by researchers
Evaluate the effectiveness of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) using the Progression-Free Survival evaluated by researchers.
Time frame: The duration is approximately 1 year
Objective Response Rate evaluated by researchers
Evaluate the effectiveness of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) using the Objective Response Rate evaluated by researchers.
Time frame: The duration is approximately 1 year
The Disease Control Rate evaluated by the researchers
Evaluate the effectiveness of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) using the Disease Control Rate evaluated by researchers.
Time frame: The duration is approximately 1 year
The Duration of Response (DOR) evaluated by the researchers
Evaluate the effectiveness of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) using the Duration of Response evaluated by researchers.
Time frame: The duration is approximately 1 year
The Time to Tumor Recurrence evaluated by the researchers
Evaluate the effectiveness of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) using the Time to Tumor Recurrence evaluated by researchers.
Time frame: The duration is approximately 1 year
Adverse events
Evaluate the safety of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) by assessing the incidence and severity of adverse events, determined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 5.0 grading scale.
Time frame: Sign the informed consent form, and until 28 days after the last medication administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Daxing District People'S Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGMengchao Hepatobiliary Hospital OF Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGThe Firstaffiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGZhongshan Hospital Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITING...and 60 more locations