Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.

Detailed Description
-----------------
This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. SHR-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect. The safety and efficacy of this study will be assessed through ORR, DCR,PFS, OS , and adverse effects as graded by CTCAE 5.0.

Official Title
-----------------
A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: SHR-1020+albumin-bound paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to RECIST 1.1 criteria. Disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy ECOG score 0-2 Adequate organ and bone marrow function The expected survival time is ≥ 12 weeks Had normal swallowing function, without dysfunction of gastrointestinal absorption Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures Exclusion Criteria: The patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel; The first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy Known to be allergic to the active ingredients or excipients in this study. Had other active malignant tumors within 5 years before entering the study. Subject with cerebral metastasis Have a clear history of serious and uncontrolled other disease or mental disorders; Other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional Chinese medicine should be used for anti-tumor therapy Other situations that the researcher considers inappropriate to participate in the research.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-1020 combined with albumin-bound paclitaxel<br>SHR-1020 combined with albumin-bound paclitaxel | Drug: SHR-1020+albumin-bound paclitaxel<br>* SHR-1020 combined with albumin-bound paclitaxel for advanced pancreatic cancer<br>* Other names: Nab-paclitaxel， Paclitaxel-albumin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR (Objective Response Rate) | Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DCR (Disease Control Rate) | Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months] | 
| PFS (Progression-Free-Survival) | From date of treatment start until the date of progression or the date of death due to any cause.Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months | 
| 6mPFS | 6-month- Progression-Free-Survival rate. Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | Up to 6 months | 
| OS (overall survival) | From date of treatment start to any cause death or last follow-up. | From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months | 
| Adverse events (per CTCAE v5.0 criteria) | To evaluate the adverse events of patients with advanced pancreatic cancer after treated with SHR-1020 plus albumin-bound paclitaxel | Up to 12months |