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)

NCT06962267 | Recruiting Phase 2

• 1 other identifier: TQB2916-II-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (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.

  Baseline up to 6 months

Secondary Outcomes (7)

• objective remission rate

  Baseline up to 9 months

• Disease Control Rate (DCR)

  Baseline up to 9 months

• Event free survival (EFS) assessed by the investigator

  Baseline up to 9 months

• Overall survival (OS)

  Baseline up to 12 months

• Duration of Response (DOR)

  Baseline up to 9 months

Study Arms (1)

TQB2916 Injection +Chemotherapy

EXPERIMENTAL

TQB2916 injection combined with Chemotherapy, 28 days as a treatment cycle.

Drug: TQB2916 Injection; Drug: Chemotherapy

Interventions

TQB2916 Injection DRUG

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.

TQB2916 Injection +Chemotherapy

Chemotherapy DRUG

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.

TQB2916 Injection +Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yi Ba, Doctor

CONTACT

13752157916; Bayi@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: April 18, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-04

Locations

CN (1)