Clinical trial NCT04814485: Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: ORR (Objective Response Rate)
timeFrame: 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 outcomes:
measure: DCR (Disease Control Rate)
timeFrame: 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]
measure: PFS (Progression-Free-Survival)
timeFrame: From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months
measure: 6mPFS
timeFrame: Up to 6 months
measure: OS (overall survival)
timeFrame: 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
measure: Adverse events (per CTCAE v5.0 criteria)
timeFrame: Up to 12months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: