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

NCT04814485 | Unknown Phase 2

• 1 other identifier: PANC-2nd-IIT-FMTN-naP
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• DCR (Disease Control Rate)

  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 caus, assessed up to 12 months

• 6mPFS

  Up to 6 months

• OS (overall survival)

  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)

  Up to 12months

Study Arms (1)

SHR-1020 combined with albumin-bound paclitaxel

EXPERIMENTAL

SHR-1020 combined with albumin-bound paclitaxel

Drug: SHR-1020+albumin-bound paclitaxel

Interventions

SHR-1020+albumin-bound paclitaxel DRUG

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

Also known as: Nab-paclitaxel， Paclitaxel-albumin

SHR-1020 combined with albumin-bound paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 24, 2021
• Study Start: April 22, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 25, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)