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

Tianjin Medical University

Status and phase

Unknown

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: SHR-1020+albumin-bound paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT04814485

PANC-2nd-IIT-FMTN-naP

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.