SHR- 1210 Combined With Paclitaxel (Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer

NCT04181645 | Completed

• 1 other identifier: CPOG1210-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single center, non-randomized, phase I trial to evaluate safety and efficacy of using the combination treatment of SHR-1210 with Paclitaxel-albumin and gemcitabine of metastatic PDAC.

Conditions

Pancreatic Cancer Stage IV

Keywords

pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• ORR：Objective Response Rate by IRC

  objective response rate evaluated by Independent Review Committee using radiographic examination according to RECIST1.1

  through study completion, an average of 2 year

Secondary Outcomes (5)

• ORR：Objective Response Rate by investigator

  through study completion, an average of 2 year

• DCR: disease control rate

  through study completion, an average of 2 year

• DoR：duration of response

  through study completion, an average of 2 year

• PFS: progression-free survival

  through study completion, an average of 2 year

• OS: overall survival

  through study completion, an average of 2 year

Study Arms (1)

SHR-120, Paclitaxel-albumin and Gemcitabine

EXPERIMENTAL

Subjects receive SHR-1210 200mg (Day 1) and Paclitaxel-albumin 125mg/m2 (Day1 and Day8) and gemcitabine 1000mg/m2 (Day 1 and Day 8) of each 21-day cycle for at most 6 cycles until documented PD or intolerable adverse event or new anti-cancer treatment or loss to follow-up or death. Subjects receive SHR-1210 200mg (Day1) to maintain after 6 cycles treatment without PD or listed situation to terminate.

Drug: Biological: SHR-1210 Drug: Gemcitabine Drug:Paclitaxel-albumin

Interventions

Biological: SHR-1210 Drug: Gemcitabine Drug:Paclitaxel-albumin DRUG

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. Gemcitabine Other Name: Gemcitabine Hydrochloride for Injection Paclitaxel-albumin Other Name: Paclitaxel-albumin Injection

SHR-120, Paclitaxel-albumin and Gemcitabine

Eligibility Criteria

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

You may qualify if:

• Aged \>= 18 years, male or female;
• Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma;
• Patients have never received systematical anti-cancer therapy;
• Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion which has never received local treatment like radiotherapy(The lesion located in previous radiotherapy areas can also be selected as target lesions if the progress confirmed.)
• ECOG:0-1;
• Expected survival\>=12 weeks;
• Essential organs function must meet the following criteria (Any blood products, growth factor, leucocyte promoting drugs, platelet promoting drugs, drugs for anemia are not allowed in 14 days before the first use of the experimental medication):
• \) Absolute neutrophil count(ANC) \>= 1.5x10\^9/L 2) Platelet \>= 85x10\^9/L 3) Hemoglobin \>= 90g/L 4) Serum Albumin \>= 30g/L 5) Total bilirubin \<= 2.0 ULN (Biliary obstructive patients after biliary drainage \<= 2.5 ULN), AST and ALT \<= 3.0 ULN (patients with liver metastasis \<= 5 ULN); 6) Creatinine clearance rate \>60 mL/min; 7) Activated Partial Thromboplastin Time and International Standardized Ratio \<= 1.5 ULN (Patients using stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin and INR is within the expected range of anticoagulants can be selected.)

You may not qualify if:

• Patients with central nervous system metastasis.
• Patients only have local advanced diseases.
• Patients have uncontrolled pleural, pericardial or abdominal effusion requiring drainage.
• Patients with history of allergy to monoclonal antibodies, any component of SHR-1210, paclitaxel(Albumin Bound) and Gemcitabine.
• Patients have ever received anti PD-1 or anti PD-L1 therapy in the past.
• Patients have accepted any experimental medication.within 4 weeks before the first dose of our experimental medication administration.
• Patients are enrolled in another clinical trial except for observational clinical trial (Non-interventional) or the follow-up of the interventional clinical trial.
• Patients accepted the last dose of anti-cancer therapy (including radiotherapy) within 4 weeks before the first dose of experimental medication administration.
• Patients who need corticosteroid or other immunosuppressive agents.
• Patients who ever received anti-cancer vaccine or have received live vaccine within 4 weeks before the first dose of administration.
• Patients who have received major surgery within 4 weeks before the first dose of administration.
• Patients with active autoimmune diseases, history of autoimmune diseases.
• History of immunodeficiency, including HIV positive test, or other acquired, congenital immunodeficiency disorders, or history of organ transplantation and allogeneic bone marrow transplantation.
• Patients with uncontrolled cardiovascular clinical symptoms or diseases.
• Severe infections occurred within 4 weeks before the first administration.

Sponsors & Collaborators

• RenJi Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

RenJiH

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

• Jiujie Cui, Haiyan Yang, Jiong Hu, Jiayu Yao, Yu Wang, Yiyi Liang, Yongchao Wang, Feng Jiao, Xiaofei Zhang, Xiao Zhang, Ting Han, Tiebo Mao, Qing Xia, Xiuying Xiao, Li-Wei Wang. Anti-PD-1 antibody combined with albumin-bound paclitaxel and gemcitabine (AG) as first-line therapy and Anti-PD-1 monotherapy as maintenance in metastatic pancreatic ductal adenocarcinoma (PDAC). J Clin Oncol 39, 2021 (suppl 15; ASCO2021 abstr e16218).

  RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Liwei Wang, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: An open label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be assigned to accept the combination treatment of SHR-120 with Paclitaxel-albumin and gemcitabine after meeting the inclusion criteria.

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 29, 2019
• Study Start: June 29, 2019
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)