pancreatic cancer
Conditions
Interventions
treatment group:SHR-A1921 combined with S-1
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Male or female subjects aged between 18 and 75 years (including 18 and 75 years old); 2) Pathologically confirmed metastatic or locally advanced unresectable Pancreatic Ductal Adenocarcinoma (PDAC), at least one measurable lesion confirming to RECIST1.1 criteria; 3) Disease progresses or intolerance for =1L systematic treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy; 4) ECOG score 0-2; 5) The expected survival time is = 12 weeks; 6) The main organ function is normal, which meets the following criteria: ? Blood routine (no blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors): a. Hb = 90 g/L; b. ANC = 1.5 × 109/L; c. PLT = 100 × 109/L; d. WBC = 3.0 × 109/L; ? Blood biochemistry: a. TBIL = 1.5 x ULN (liver metastasis patients = 2 x ULN); b. ALT and AST = 2.5 × ULN (liver metastasis patients = 5 × ULN); c. Serum Cr = 1.5 × ULN; d. Plasma albumin = 30g/L; 7) Previously received surgery (excluding diagnostic surgery), macromolecular targeted therapy, anti-tumor immunotherapy, and completed treatment (last medication) more than 4 weeks after the first medication; The last chemotherapy was more than 2 weeks after the first medication; Small molecule targeted drugs (including other oral targeted drugs used in clinical trials) with a last use lasting more than 5 half-lives or 4 weeks from the first use (whichever is longer); Those who have previously received interventional therapy, ablation therapy, or other local treatments and radiotherapy, and have completed treatment more than 2 weeks before the first medication. 8) Female subjects of childbearing age must undergo a serum pregnancy test within 7 days before the commencement of the study and the results are negative, and are willing to use a medically approved high potency contraceptive method during the study period and within 3 months after the last administration of the study drug; For male subjects whose partner is a female of childbearing age, they should be agree to use an effective method of contraception during the study period and for 3 months after administration of the last study; 9) Had normal swallowing function, without dysfunction of gastrointestinal absorption; 10) Willing to consent and signed the informed consent, and able comply with the planned visit.
Exclusion criteria
Exclusion criteria: 1) Known to be allergic to the active ingredients or excipients in this study; 2) Other malignant tumors occurred in the past 5 years, except for cured skin basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ and papillary thyroid carcinoma; 3) Patients with active central nervous system metastases; 4) Has a bleeding tendency or abnormal clotting function; 5) urinary protein=++ or 24h urinary protein > 1.0g; 6) Severe gastrointestinal diseases in clinical practice; 7) Within 6 months before enrollment, patients with severe cardiovascular and cerebrovascular thromboembolism, NYHA grade 2 or above cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 8) Hypertension with poor drug control; 9) Participated in clinical trials of any drug or medical device within 4 weeks prior to initial administration; 10) Suffering from congenital or acquired immune dysfunction; 11) With active autoimmune disease or a history of autoimmune disease; 12) Systemic therapy with corticosteroid or other immunosuppressive agents within 14 days before the first dose of study drug; In the absence of active autoimmune diseases, inhaled and topical use corticosteroids or adrenal hormone replacement therapy with a dose = 10mg/day prednisone therapeutic dose are NOT excluded; 13) Other situations that the researcher considers inappropriate to participate in the research; 14) Late stage patients who have symptoms, have spread to the internal organs, and are at risk of life-threatening complications in the short term; Perform fluid drainage, and those who remain stable for at least 2 weeks after drainage can be enrolled in the group; 15) Individuals with interstitial lung disease, non infectious pneumonia, severe and uncontrolled internal medicine diseases, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects); 16) The patient has previously used TROP2-ADC or drugs containing topoisomerase I inhibitors; 17) The patient has previously used fluorouracil based anti-tumor drugs (excluding those used during neoadjuvant and adjuvant therapy, and without recurrence or metastasis within 6 months after treatment); 18) The patient has a history of moderate or severe oral mucosal inflammation or oral complications;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactMeng Zhiqiang/Xie Jing
Fudan University Shanghai Cancer Center
Outcome results
None listed