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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2916 Injection +Chemotherapy | Experimental | TQB2916 injection combined with Chemotherapy, 28 days as a treatment cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline up to 9 months |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
Comorbid diseases and medical history:
Tumor-related symptoms and treatments:
Research treatment-related:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Ba, Doctor | Contact | 13752157916 | Bayi@tjmuch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| 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. |
|
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).
| Baseline up to 9 months |
| 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. | Baseline up to 9 months |
| Overall survival (OS) | From randomization to the time of death from any cause. | Baseline up to 12 months |
| 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). | Baseline up to 9 months |
| 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. | Baseline up to 9 months |
| The incidence of immunogenicity (ADA) | The incidence of immunogenicity (ADA) | Baseline up to 9 months |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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