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To evaluate the efficacy of PD-L1/CTLA4 BsAb for the second line treatment and the combination with chemotherapy for the first line treatment in pancreatic cancer
Subjects who signed the informed consent were assigned to three cohorts according to the actual treatment status. Cohort 1 enrolled subjects receiving PD-L1/CTLA4 BsAb 5mg/kg iv Q2W for 2nd treatment; cohort 2 enrolled subjects receiving PD-L1/CTLA4 BsAb in combination with gemcitabine/albumin- paclitaxel as 1st treatment for 4-6 cycles with PD-L1/CTLA4 BsAb monotherapy maintainence; cohort 3 enrolled subjects received systemic chemotherapy, receiving PD-L1/CTLA4 BsAb combined with oxaliplatin / irinotecan / leucovorin / fluorouracil (FOLFIRINOX) as 1st treatment for 4-6 cycles withPD-L1/CTLA4 BsAb monotherapy maintainence; until disease progression according to RECIST 1.1, intolerable toxicity, withdrawal, death, 2-yr treatment,who comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-L1/CTLA4 BsAb | Experimental | For 2nd line treatment,PD-L1/CTLA4 BsAb 5mg/kg Q2W |
|
| PD-L1/CTLA4 BsAb + GP | Experimental | For 1st line treatment,PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Gemcitabine 1000 mg/m2 and Nab-paclitaxel 125 mg/m2 , 28days/cycle |
|
| PD-L1/CTLA4 BsAb + FOLFIRINOX | Experimental | For 1st line treatment,PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Oxaliplatin 68 or 85 mg/m2, Irinotecan 135 or 150 or 180 mg/m2, Calcium Folate 400 mg/m2, Fluorouracil 2400mg/m2, 14 days/cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-L1/CTLA4 BsAb | Drug | PD-L1/CTLA4 BsAb 5mg/kg, iv,Q2W |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | objective response rate | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | Disease Control Rate | 2 years |
| DOR | Duration of Response | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiwei Guo, Doctor | Contact | 86-18621500666 | gestwa@163.com | |
| Suizhi Gao, Doctor | Contact | 86-13167137990 | gaosuizhi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gang Jin, Doctor | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| C000627770 | folfirinox |
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| GP | Combination Product | Gemcitabine 1000mg/m2, iv, D1,8,15, 28days/cycle; nab-Paclitaxel 125mg/m2,iv,D1,8,15, 28days/cycle; |
|
|
| FOLFIRINOX | Combination Product | Fluorouracil 2400mg/m2,iv,D1, 14days/cycle; Oxaliplatin 68-85mg/m2,iv, D1,14days/cycle;Irinotecan135-180mg/m2,iv, D1, 14days/cycle;Calcium Folate 400mg/m2,iv, D1, 14days/cycle; |
|
|
| TTP |
Time to Response |
| 2 years |
| PFS | Progression Free Survival | 2 years |
| OS | Overall Survival | 2 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D014498 | Uracil |
| D011744 | Pyrimidinones |