TQB2868 plus anlotinib with chemotherapy versus placebo plus chemotherapy for first-line metastatic pancreatic ductal adenocarcinoma

A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules to Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

This trial will see if adding TQB2868 injection and anlotinib capsules to first-line chemotherapy helps adults with newly diagnosed metastatic pancreatic ductal adenocarcinoma live longer than chemotherapy with placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 566 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation, prednisone, anlotinib, chemotherapy
• Locations: 70 sites (Hefei, Anhui and 69 other locations)
• Trial ID: NCT07165951 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label, placebo-controlled, multicenter Phase 3 trial with overall survival as the primary endpoint. Eligible patients with untreated metastatic pancreatic ductal adenocarcinoma are randomized 1:1 to receive TQB2868 injection and anlotinib capsules combined with gemcitabine and paclitaxel versus placebo combined with the same chemotherapy backbone. The trial enrolls adults 18–75 years with histologic or cytologic confirmation and at least one measurable lesion per RECIST v1.1, and excludes those who received prior systemic therapy for metastatic disease (with specific allowances for prior adjuvant therapy if recurrence was ≥6 months after). Sites include multiple hospitals in China and participants are followed for survival outcomes and safety.

Who should consider this trial

Good fit: Adults aged 18–75 with confirmed metastatic pancreatic ductal adenocarcinoma who have not received prior systemic therapy for metastatic disease and who have at least one measurable lesion are ideal candidates.

Not a fit: Patients who have already received systemic anti-tumor therapy for metastatic disease, who relapsed within six months of prior adjuvant therapy, or who do not have measurable disease are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding TQB2868 and anlotinib to standard chemotherapy could extend overall survival for people with metastatic pancreatic ductal adenocarcinoma.

How similar studies have performed: Combining anti-angiogenic TKIs like anlotinib with chemotherapy has shown mixed results in other cancers and remains under study, while TQB2868 appears to be experimental with limited prior phase data.

Eligibility criteria

Inclusion Criteria:

1. The subjects voluntarily joined this study, signed the Informed Consent Form (ICF), and showed good compliance;
2. On the date of signing the ICF, aged between 18 and 75 years old (inclusive);
3. Pancreatic ductal adenocarcinoma (PDAC) diagnosed by tissue or cytology;
4. 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;
5. 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;

7\. Eastern Cooperative Oncology Group (ECOG) score from 0 to 1; Expected survival is greater than 12 weeks; 9. The laboratory inspection meets the protocol standards; 10. Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study, and have a negative serum test within 7 days before enrollment in the study; Men should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study period;

Exclusion Criteria:

1. Have had or currently have other malignant tumors within the past 5 years prior to the first use of medication;
2. 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);
3. 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;
4. 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;
5. Subjects who experience any bleeding or bleeding events ≥ NCI CTCAE v5.0 grade 3 within 4 weeks prior to the first administration;
6. 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);
7. 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;
8. Active syphilis infected individuals who require treatment;
9. History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia;
10. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
11. Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation;
12. Subjects with any severe and/or uncontrolled illnesses;
13. Subjects who require immunosuppressive therapy, systemic or absorbable local hormone therapy to achieve immunosuppression and continue to use it within 7 days prior to the first dose (excluding corticosteroids with a daily dose of\<10 mg prednisone or other therapeutic hormones);
14. Tumor related symptoms are difficult to control;
15. Known to be allergic to the components of research drug excipients;
16. Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication;
17. Pregnant or breastfeeding subjects; According to the judgment of the researchers, there are serious situations that pose a threat to the safety of the subjects or affect their ability to complete the study.

Where this trial is running

Hefei, Anhui and 69 other locations

• The First Affiliated Hospital of USTC Anhui Provincial Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• Peking University First Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Friendship Hospital,Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The Fifth Medical Center of Chinese People's Liberation Army General Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Daxing District People'S Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Mengchao Hepatobiliary Hospital OF Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• The Firstaffiliated Hospital of Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• Zhongshan Hospital Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• Gansu Provincial Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Not_yet_recruiting)
• Lanzhou University Second Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
• Sun Yat-Sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Longhua District Central Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Guangxi Cancer Institute — Nanning, Guangxi, China (Not_yet_recruiting)
• Guizhou Medical University Affiliated Cancer Hospital Co., LTD — Guiyang, Guizhou, China (Not_yet_recruiting)
• Affiliated Hospital of Zunyi Medical Universityl — Zunyi, Guizhou, China (Not_yet_recruiting)
• Hainan general hospital — Haikou, Hainan, China (Not_yet_recruiting)
• Cancer Hospital Chinese Academy pf Medical Sciences — Langfang, Hebei, China (Not_yet_recruiting)
• Tangshan peopel's Hospital — Tangshan, Hebei, China (Not_yet_recruiting)
• Daqing Oilfield General Hospital — Daqing, Heilongjiang, China (Not_yet_recruiting)
• Harbin Medical University Cancer Hospital — Haerbin, Heilongjiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Not_yet_recruiting)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• People's Hospital of Hunan Province — Changsha, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• Peking University Cancer Hospital Inner Mongolia Hospital — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
• Jiangyin People'S Hospital — Jiangyin, Jiangsu, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Nantong Tumor Hospital — Nantong, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Jilin Cancer Hospital — Changchun, Jilin, China (Not_yet_recruiting)
• The first hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Liaoning Cancer Hospital — Shenyang, Liaoning, China (Not_yet_recruiting)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• The Second Affiliated Hospital of PLA Air Force Military Medical University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi 'An Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
• Linyi people's hospital — Linyi, Shandong, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Xianjun Yu, Doctor

Conditions Metastatic Pancreatic Ductal Adenocarcinoma