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

NCT ID: NCT04814485

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2023-07-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-1020 combined with albumin-bound paclitaxel

SHR-1020 combined with albumin-bound paclitaxel

Group Type: EXPERIMENTAL

SHR-1020+albumin-bound paclitaxel

Intervention Type: DRUG

SHR-1020 combined with albumin-bound paclitaxel for advanced pancreatic cancer

Interventions

SHR-1020+albumin-bound paclitaxel

SHR-1020 combined with albumin-bound paclitaxel for advanced pancreatic cancer

Intervention Type: DRUG

Other Intervention Names

Nab-paclitaxel， Paclitaxel-albumin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

jihui Hao, MD

Role: primary

ec_tjcih@126.com

022-23524155

chuntao Gao, MD

Role: backup

Other Identifiers

PANC-2nd-IIT-FMTN-naP

Identifier Type: -

Identifier Source: org_study_id