Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New triple therapy takes on pancreatic cancer

NCT ID NCT06767813

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Nov 2026

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Pancreatic ductal adenocarcinoma are added.

Vår säkerhetsrekommendation!

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.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Jiangsu Provincial People's Hospital

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Nanjing Drum Tower Hospital

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210000, China

  • The First Affiliated Hospital of Soochow University

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Wenzhou Medical University

    NOT_YET_RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The Second Affiliated Hospital of Zhengzhou University

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450039, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.