New triple therapy takes on pancreatic cancer
NCT ID NCT06767813
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This Phase 2 trial is testing whether adding an experimental immunotherapy (TQB2868) and a targeted drug (anlotinib) to standard chemotherapy can help people with pancreatic cancer that has spread. The study will enroll 80 adults who have not had prior treatment. Researchers will measure how long the cancer stays under control and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TQB2868 injection (a bifunctional fusion protein targeting PD-1 and TGF-βRII), anlotinib capsules, gemcitabine injection, and albumin paclitaxel injection
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for pancreatic cancer, potentially improving how long patients live without their cancer growing.
- What could go wrong
- This is an early Phase 2 trial with only 80 participants, so results may not apply to all patients. The combination also carries risks of side effects from chemotherapy and the immune-targeting drug.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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: * 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 prior to enrollment and must not be breastfeeding. Exclusion Criteria: * Subjects with a history of or concurrent diagnosis of other malignant tumors within the past 5 years. * Unresolved toxicities from prior treatments exceeding Grade 1 according to Common Terminology Criteria (CTC) AE criteria, excluding alopecia. * Major surgical procedures, significant traumatic injuries, or unhealed wounds or fractures within 28 days prior to the first dose. * Any bleeding or hemorrhagic event of ≥ Grade 3 according to CTC AE criteria within 4 weeks prior to the first dose. * Arterial or venous thrombotic events within 6 months prior to the first dose. * Active gastric or duodenal ulcers, perforations, persistent positive fecal occult blood tests, ulcerative colitis, or other gastrointestinal bleeding conditions within 6 months prior to the first dose; or other bleeding conditions as assessed by the investigator. * Hepatitis B virus (HBV)-infected patients unable to adhere to consistent antiviral therapy, or Hepatitis C virus (HCV)-infected patients (positive for HCV Ab or HCV RNA) deemed unstable by the investigator or requiring continued antiviral therapy without consistent adherence. * History of substance abuse involving psychotropic drugs that cannot be discontinued or presence of psychiatric disorders. * Symptomatic interstitial lung disease or conditions likely to cause drug-induced lung toxicity or related pneumonitis. * Presence of any severe and/or uncontrolled diseases. * Histological or cytological confirmation of other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, or pancreatoblastoma. * Tumors confirmed via imaging (CT or MRI) to have invaded major blood vessels, with the investigator deeming a high likelihood of fatal hemorrhage during the study. * Tumors confirmed via imaging (CT or MRI) to have invaded the gastrointestinal tract, with a high risk of bleeding based on endoscopy and investigator assessment. * Known central nervous system metastases and/or carcinomatous meningitis. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage, as assessed by the investigator. * History of severe allergic reactions to biologic agents or known hypersensitivity to any component of TQB2868 injection. * Chronic treatment with systemic corticosteroids or other immunosuppressive agents within 28 days prior to the first dose, and continued use of such medications within 2 weeks after the first dose. * Receipt of live attenuated vaccines within 28 days prior to the first dose or planned administration of live attenuated vaccines during the study. * Systemic therapy required within 2 years prior to the first dose for any condition. Alternative therapies are not considered systemic therapy. * Participation in other clinical trials involving anti-tumor drugs within 28 days prior to the first dose. * Any comorbidities or conditions deemed by the investigator to pose severe risks to the subject's safety or the completion of the study, or any other reasons rendering the subject unsuitable for enrollment.
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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.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, 450000, China
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Jiangsu Provincial People's Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Nanjing Drum Tower Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITINGSuzhou, Jiangsu, 215006, China
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The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITINGWenzhou, Zhejiang, 325000, China
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The Second Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, 450039, China
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Other studies related to the condition(s) this trial covers.
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- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a vaccine stop GI cancers from returning?
- AI reads tumor slides to match cancer patients with trials
- Triple therapy aims to stall pancreatic cancer