First-line treatment for metastatic pancreatic cancer using TQB2916 with chemotherapy

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 study is testing a new treatment combining TQB2916 with chemotherapy to see if it helps people with metastatic pancreatic cancer feel better and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry)
• Drugs / interventions: prednisone
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06962267 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of TQB2916 injection combined with gemcitabine and albumin-bound paclitaxel as a first-line treatment for patients with metastatic pancreatic cancer. It is designed as a single-arm, open-label study, meaning all participants will receive the same treatment without a control group. The trial aims to determine how well this combination therapy works in managing the disease and improving patient outcomes. Participants will be closely monitored for any side effects and overall response to the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed pancreatic ductal adenocarcinoma and at least one measurable lesion.

Not a fit: Patients with other malignancies or significant comorbid diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with metastatic pancreatic cancer.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches using chemotherapy in pancreatic cancer have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Comorbid diseases and medical history:

  1. 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor-infiltrating basement membrane)\];
  2. Unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 caused by any previous treatment, excluding alopecia;
  3. Have received major surgical treatment, obvious traumatic injury, or have long-term unhealed wounds or fractures within 28 days before the first medication;
  4. Patients who experienced any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first administration;
  5. 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.
  6. 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.
  7. Active syphilis patients;
  8. Those with a history of abuse of psychotropic drugs and who are unable to quit or have mental disorders;
  9. Symptomatic interstitial lung disease, as well as conditions that may cause drug-induced pulmonary toxicity or associated pneumonia;
  10. Subjects with any severe and/or uncontrolled diseases.
* Tumor-related symptoms and treatments:

  1. 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;
  2. Subjects with known central nervous system metastases and/or cancerous meningitis;
  3. Uncontrolled pleural effusion, pericardial effusion or ascites that still require repeated drainage (as determined by the researcher).
* Research treatment-related:

  1. There is a history of severe allergy to large molecule drugs in the past, or allergy to known components of TQB2916 injection;
  2. 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);
  3. 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;
  4. 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.

Where this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Yi Ba, Doctor

Conditions: Pancreatic Cancer