Skin and adnexal tumors
Conditions
Interventions
Group 1 :Penpulimab + PF
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Before implementing any trial-related procedures, sign a written informed consent; 2. Age: >= 18 years old and 3 months; 9. The organ function is good; 10. For female subjects of childbearing age, they should receive a urine or serum pregnancy test within 3 days before receiving the first study drug administration (1st cycle, 1st day) and the result is negative. If the urine pregnancy test result cannot be confirmed negative, a blood pregnancy test will be ordered. Women of non-reproductive age are defined as postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of pregnancy, all subjects (whether male or female) must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , nephritis, hyperthyroidism, hypothyroidism, etc.; 2. Subjects are using immunosuppressants, or systemic, or absorbable local hormone therapy to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other therapeutic hormones), and within 2 weeks before enrollment still in use; 3. The subject has previously received other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1; severe allergic reactions to other monoclonal antibodies; 4. Less than 4 weeks before the study medication or may receive live vaccines during the study; 5. Currently participating in interventional clinical research treatment, or have received other research drugs or used research device treatment within 4 weeks before the first administration; 6. Received major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks before the study or expected to need major surgery during the study treatment; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Have not fully recovered from the toxicity and/or complications caused by any intervention before starting treatment (ie, CTCAE <= grade 1 or reaching baseline, excluding fatigue or alopecia); 9. Long-term unhealed wounds or fractures; 10. History of gastrointestinal perforation and/or fistula occurred within 6 months before the selected treatment; or excessive arterial/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 11. Pregnant or lactating women; 12. There are any serious or uncontrollable systemic diseases; 13. Medical history or disease evidence that may interfere with the test results, prevent the subject from fully participating in the study, abnormal treatment or laboratory test values, or other situations that the investigator believes are not suitable for enrollment. The investigator believes that there are other potential risks that are not suitable for participation this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to progression;duration of response;adverse event; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed