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AzTrials

Pancreatic CancerPhase 2NCT06962267

A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type)

A Phase 2 study testing TQB2916 Injection and Chemotherapy in people with Pancreatic Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This trial was a single-arm, open-label design to evaluate the efficacy and safety of "TQB2916+ gemcitabine + albumin-paclitaxel" as the first-line treatment for metastatic pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
TQB2916 Injection and Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
18 Apr 2025to Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects voluntarily joined this study and signed the informed consent form;
  • Age: 18-75 years old (the time of signing the informed consent form, including the critical value);
  • Pancreatic ductal adenocarcinoma confirmed by tissue or cytology (excluding other mixed pancreatic cancers);
  • Have at least one measurable lesion according to the RECIST 1.1 standard;
  • Without any systematic anti-tumor treatment;
  • The Eastern Cooperative Oncology Group (ECOG) score is 0-1, and the expected survival period is more than 3 months;
  • The main organs function well;
  • Patients must adopt reliable contraceptive measures during the study period and within 6 months after the end of the study period;The serum pregnancy test must be negative within 7 days before enrollment in the study, and the subjects must be non-lactating.

Who cannot join

  • Comorbid diseases and medical history:
  • Within 5 years, the subject has had or simultaneously suffered from other malignant tumors (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);Patients with other malignant tumors, but the following two situations can be enrolled: other malignant tumors treated by single surgery, achieving R0 resection and no recurrence or metastasis within 5 years;Cured cervical carcinoma in situ, cutaneous basal cell carcinoma, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor-infiltrating basement membrane)];
  • Unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 caused by any previous treatment, excluding alopecia;
  • Have received major surgical treatment, obvious traumatic injury, or have long-term unhealed wounds or fractures within 28 days before the first medication;
  • Patients who experienced any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first administration;
  • Those who have experienced hyperarterial/venous thrombotic events within 6 months before the first administration, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism.
Show all 22Show fewer
  • hepatitis B virus (HBV) virus-infected individuals cannot receive regular antiviral treatment throughout the entire course.Hcv-infected individuals (HCV Ab or HCV RNA positive) : Researchers determine that they are in an unstable state or need to continue antiviral treatment. They cannot receive regular antiviral treatment in the study.
  • Active syphilis patients;
  • Those with a history of abuse of psychotropic drugs and who are unable to quit or have mental disorders;
  • Symptomatic interstitial lung disease, as well as conditions that may cause drug-induced pulmonary toxicity or associated pneumonia;
  • Subjects with any severe and/or uncontrolled diseases.
  • Tumor-related symptoms and treatments:
  • Imaging (CT or MRI) shows that the tumor has invaded around important blood vessels, and the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive hemorrhage during the subsequent study period;
  • Subjects with known central nervous system metastases and/or cancerous meningitis;
  • Uncontrolled pleural effusion, pericardial effusion or ascites that still require repeated drainage (as determined by the researcher).
  • Research treatment-related:
  • There is a history of severe allergy to large molecule drugs in the past, or allergy to known components of TQB2916 injection;
  • Those who received chronic treatment with systemic hormones or other immunosuppressants (dose >10mg/ day prednisone or other equivalent therapeutic hormones) within 28 days before the start of administration in this study and still need to continue using hormones or immunosuppressants within 2 weeks after the first trial administration (except temporarily);
  • The history of attenuated live vaccine inoculation within 28 days before the start of the study treatment or the planned attenuated live vaccine inoculation during the study period;
  • An active autoimmune disease that required systemic treatment (such as the use of disease-relieving drugs, corticosteroids or immunosuppressants) occurred within 2 years prior to the first medication.
  • Participated in clinical trials of other anti-tumor drugs within 28 days before the start of administration in this study;
  • Subjects who, based on the researcher's judgment, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered to have other reasons and are not suitable for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yi Ba, Doctor contact

13752157916

Bayi@tjmuch.com

China1 site, 1 recruiting

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100730

    Yi Ba, Doctor, 13752157916, Bayi@tjmuch.com

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of TQB2916 Injection Combined With Gemcitabine and Albumin-paclitaxel as First-line Treatment for Metastatic Pancreatic Cance

This trial was a single-arm, open-label design to evaluate the efficacy and safety of "TQB2916+ gemcitabine + albumin-paclitaxel" as the first-line treatment for metastatic pancreatic cancer.

Being tested
TQB2916 Injection, Chemotherapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2916 InjectionDrug

    A Phase II clinical study to evaluate the efficacy and safety of TQB2916 injection combined with gemcitabine and albumin-paclitaxel as first-line treatment for metastatic pancreatic cancer.

  • ChemotherapyDrug

    Chemotherapy is a systematic treatment.Chemotherapy drugs go into the body orally or intravenously, and they circulate throughout the body, and because of that, they can be used for advanced cancer, and they can also be effective against metastasized cancer cells.There are many chemotherapeutics, but the underlying mechanism is to kill fast growing cells.

Study groups in NCT06962267
Study groupRoleWhat they receive
TQB2916 Injection +ChemotherapyExperimentalTQB2916 injection combined with Chemotherapy, 28 days as a treatment cycle.
Receives: Drug: TQB2916 Injection; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month progression-free survival rate

    The ratio of the time from the start of treatment to 6 months for the subjects to the time from the start of treatment to tumor progression for the subjects.

    Measured: Baseline up to 6 months

Secondary outcomes (7)

  1. objective remission rate

    Usually, the proportion of patients whose tumor volume shrinks by 30% is the sum of the proportions of complete response (CR) and partial response (PR).

    Measured: Baseline up to 9 months

  2. Disease Control Rate (DCR)

    The proportion of cases that achieved remission (CR+PR) and stable disease (SD) after treatment, that is, the proportion of patients without disease progression (PD).

    Measured: Baseline up to 9 months

  3. Event free survival (EFS) assessed by the investigator

    From the time of random initiation to the occurrence of a predetermined event, an event may include death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc.

    Measured: Baseline up to 9 months

  4. Overall survival (OS)

    From randomization to the time of death from any cause.

    Measured: Baseline up to 12 months

  5. Duration of Response (DOR)

    The period from the first judgment of complete response (CR) or partial response (PR) to the discovery of disease progression (PD).

    Measured: Baseline up to 9 months

  6. Adverse event rate

    The occurrence of adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events; The evaluation was conducted based on the standard of CTCAE 5.0.

    Measured: Baseline up to 9 months

  7. The incidence of immunogenicity (ADA)

    The incidence of immunogenicity (ADA)

    Measured: Baseline up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2025
  2. Study start18 Apr 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06962267
Sponsor's protocol ID
TQB2916-II-01
Status last verified
Apr 2025
First submitted
30 Apr 2025
Last updated
8 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQB2916 Injection and Chemotherapy in people with Pancreatic Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi Ba, Doctor (13752157916, Bayi@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month progression-free survival rate (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06962267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

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