New hope for pancreatic cancer: dual antibody plus targeted pill tested in major trial
NCT ID NCT07165951
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether a new combination of drugs—TQB2868 (a dual antibody) plus anlotinib capsules—works better than standard chemotherapy for people with metastatic pancreatic cancer that has spread. About 566 participants will be randomly assigned to receive either the new combo or placebo plus chemo. The main goal is to see if the new treatment helps people live longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TQB2868 (a dual antibody targeting PD-L1 and TGF-beta) combined with anlotinib hydrochloride capsules
- What this could lead to
- If successful, this could offer a new first-line treatment option that extends survival for people with metastatic pancreatic cancer.
- What could go wrong
- This is an early-stage Phase 3 trial, and the combination may not improve survival over standard chemotherapy. Side effects from the dual antibody and anlotinib could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 566 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic pancreatic ductal adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
71 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Affiliated Hospital of North Sichuan Medical College
NOT_YET_RECRUITINGNanchong, Sichuan, 637000, China
-
Affiliated Hospital of Zunyi Medical Universityl
NOT_YET_RECRUITINGZunyi, Guizhou, 563000, China
-
Anhui Provincial Cancer Hospital
NOT_YET_RECRUITINGHefei, Anhui, 230031, China
-
Beijing Daxing District People'S Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 102699, China
-
Beijing Friendship Hospital,Capital Medical University
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100050, China
-
Cancer Hospital Chinese Academy pf Medical Sciences
NOT_YET_RECRUITINGLangfang, Hebei, 065000, China
-
Daqing Oilfield General Hospital
NOT_YET_RECRUITINGDaqing, Heilongjiang, 163001, China
-
First Hospital of Shanxi Medical University
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030045, China
-
Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
-
Gansu Provincial Hospital
NOT_YET_RECRUITINGLanzhou, Gansu, 730000, China
-
Guangxi Cancer Institute
NOT_YET_RECRUITINGNanning, Guangxi, 530000, China
-
Guizhou Medical University Affiliated Cancer Hospital Co., LTD
NOT_YET_RECRUITINGGuiyang, Guizhou, 550001, China
-
Hainan general hospital
NOT_YET_RECRUITINGHaikou, Hainan, 570311, China
-
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITINGHaerbin, Heilongjiang, 150000, China
-
Henan Cancer Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, 450000, China
-
Hubei Cancer Hospital
NOT_YET_RECRUITINGWuhan, Hubei, 430079, China
-
Hunan Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410000, China
-
Jiangsu Province Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210029, China
-
Jiangyin People'S Hospital
NOT_YET_RECRUITINGJiangyin, Jiangsu, 214431, China
-
Jilin Cancer Hospital
NOT_YET_RECRUITINGChangchun, Jilin, 130000, China
-
Lanzhou University Second Hospital
NOT_YET_RECRUITINGLanzhou, Gansu, 730030, China
-
Liaoning Cancer Hospital
NOT_YET_RECRUITINGShenyang, Liaoning, 110000, China
-
Linyi Cancer Hospital
NOT_YET_RECRUITINGLiyi, Shandong, 276034, China
-
Linyi people's hospital
NOT_YET_RECRUITINGLinyi, Shandong, 276000, China
-
Longhua District Central Hospital
NOT_YET_RECRUITINGShenzhen, Guangdong, 518000, China
-
Mengchao Hepatobiliary Hospital OF Fujian Medical University
NOT_YET_RECRUITINGFuzhou, Fujian, 350001, China
-
Nanjing Drum Tower Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
-
Nantong Tumor Hospital
NOT_YET_RECRUITINGNantong, Jiangsu, 226361, China
-
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITINGNingbo, Zhejiang, 315100, China
-
Peking University Cancer Hospital Inner Mongolia Hospital
NOT_YET_RECRUITINGHohhot, Inner Mongolia, 10000, China
-
Peking University First Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100034, China
-
People's Hospital of Hunan Province
NOT_YET_RECRUITINGChangsha, Hunan, 410005, China
-
People's Hospital of Xinjiang Uygur Autonomous Region
NOT_YET_RECRUITINGÜrümqi, Xinjiang, 830000, China
-
Qilu Hospital of Shandong University
NOT_YET_RECRUITINGJinan, Shandong, 250012, China
-
Shanghai General Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 201620, China
-
Shanghai Sixth People's Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200233, China
-
Shanxi Cancer Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030000, China
-
Shaoxing People's Hospital
NOT_YET_RECRUITINGShaoxing, Zhejiang, 312000, China
-
Sichuan Cancer Hospital
NOT_YET_RECRUITINGChengdu, Sichuan, 610041, China
-
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, 311000, China
-
Sun Yat-Sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510000, China
-
Sun Yat-Sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510062, China
-
Tangshan peopel's Hospital
NOT_YET_RECRUITINGTangshan, Hebei, 063001, China
-
The Affiliated Hospital Of Medical College Qingdao University
NOT_YET_RECRUITINGQingdao, Shandong, 266000, China
-
The Affiliated Hospital of Southwest Medical University
NOT_YET_RECRUITINGLuzhou, Sichuan, 646000, China
-
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITINGXuzhou, Jiangsu, 221004, China
-
The Fifth Medical Center of Chinese People's Liberation Army General Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100071, China
-
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, 400010, China
-
The First Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510030, China
-
The First Affiliated Hospital of Henan University of Science & Technology
NOT_YET_RECRUITINGLuoyang, Henan, 471000, China
-
The First Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITINGKunming, Yunnan, 650000, China
-
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, 330006, China
-
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITINGSuzhou, Jiangsu, 215006, China
-
The First Affiliated Hospital of USTC Anhui Provincial Hospital
NOT_YET_RECRUITINGHefei, Anhui, 230001, China
-
The First Affiliated Hospital of Xi 'An Jiaotong University
NOT_YET_RECRUITINGXi'an, Shaanxi, 710061, China
-
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, 450000, China
-
The First Hospital of China Medical University
NOT_YET_RECRUITINGShenyang, Liaoning, 110801, China
-
The First Hospital of Lanzhou University
NOT_YET_RECRUITINGLanzhou, Gansu, 730000, China
-
The Firstaffiliated Hospital of Xiamen University
NOT_YET_RECRUITINGXiamen, Fujian, 361001, China
-
The Second Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, 310009, China
-
The Second Affiliated Hospital of PLA Air Force Military Medical University
NOT_YET_RECRUITINGXi'an, Shaanxi, 710038, China
-
The first hospital of Jilin University
NOT_YET_RECRUITINGChangchun, Jilin, 130000, China
-
Tianjin Cancer Hospital Airport Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300300, China
-
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300300, China
-
Wenzhou Medical University Affiliated First Hospital
NOT_YET_RECRUITINGWenzhou, Zhejiang, 325000, China
-
Xiangya Hospital of Central South University
RECRUITINGChangsha, Hunan, 410008, China
-
Xiangyang Central Hospital
NOT_YET_RECRUITINGXiangyang, Hubei, 441021, China
-
Yunnan Cancer Hospital
NOT_YET_RECRUITINGKunming, Yunnan, 650118, China
-
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITINGWuhan, Hubei, 430000, China
-
Zhongshan Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200030, China
-
Zhongshan Hospital Xiamen University
NOT_YET_RECRUITINGXiamen, Fujian, 361001, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug candidate takes aim at Hard-to-Treat pancreatic cancer
- Can a Two-Drug combo tame Hard-to-Treat pancreatic cancer?
- Can a One-Two punch of radiation and immunotherapy tame pancreatic cancer?
- Can an immunotherapy cocktail slow pancreatic cancer? a new trial aims to find out.
- Smart drug delivers chemo directly to pancreatic cancer cells
- Engineered T-Cells take aim at Hard-to-Treat pancreatic cancer