Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Pl… (NCT07165951) | Clinical Trial Compass
RecruitingPhase 3
Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
China566 participantsStarted 2025-12-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subjects voluntarily joined this study, signed the Informed Consent Form (ICF), and showed good compliance;
. On the date of signing the ICF, aged between 18 and 75 years old (inclusive);
. Pancreatic ductal adenocarcinoma (PDAC) diagnosed by tissue or cytology;
. According to the American Joint Commission on Cancer (AJCC) 8th Edition Tumor, Node, Metastasis (TNM) staging system for pancreatic cancer, patients with stage IV metastatic pancreatic cancer;
. Have not received any systemic anti-tumor treatment or investigational drug therapy; If receiving neoadjuvant/adjuvant therapy, the time interval between the last administration and recurrence/progression must be ≥ 6 months, and the toxicity related to anti-tumor therapy has recovered to ≤ level 1 or the toxicity level specified in the inclusion criteria (excluding hair loss); According to RECIST v1.1, there is at least one measurable lesion. If the lesion has undergone local treatment (radiotherapy, ablation, interventional therapy, etc.) in the past, it must be clearly proven to have progressed in accordance with RECIST v1.1 before it can be considered a measurable lesion;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival
Timeframe: The duration is approximately 2 years
Trial details
NCT IDNCT07165951
SponsorShanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
. Have had or currently have other malignant tumors within the past 5 years prior to the first use of medication;
. There are various factors that affect intravenous injection, venous blood collection diseases, or oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
. Adverse reactions from previous treatments have not recovered to NCI CTCAE v5.0 score ≤ 1, except for toxicity that has been determined by researchers to have no safety risks, such as grade 2 hair loss, grade 2 peripheral neurotoxicity, non clinically significant, and asymptomatic laboratory abnormalities;
. Those who have received major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks before the first medication, or have long-term untreated wounds or fractures;
. Subjects who experience any bleeding or bleeding events ≥ NCI CTCAE v5.0 grade 3 within 4 weeks prior to the first administration;
. Individuals who have experienced arterial/venous thrombotic events within 6 months prior to the first administration, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, or any other history of severe thromboembolism (implantable venous infusion port or catheter-related thrombosis, or superficial vein thrombosis is not considered "severe" thromboembolism);
. hepatitis B virus (HBV) infected individuals cannot receive regular antiviral treatment throughout the entire process; HCV infected individuals (HCV Ab or HCV RNA positive): Researchers determine that they are in an unstable state or need to continue antiviral treatment. Regular antiviral treatment cannot be accepted during the study;
. Active syphilis infected individuals who require treatment;