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

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

SHR-1020+albumin-bound paclitaxel

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR-1020 combined with albumin-bound paclitaxel

Arm Description

SHR-1020 combined with albumin-bound paclitaxel

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

OS (overall survival)

From date of treatment start to any cause death or last follow-up.

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

Full Information

NCT ID

NCT04814485

First Posted

March 17, 2021

Last Updated

May 21, 2021

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04814485

Brief Title

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

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 22, 2021 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHR-1020 combined with albumin-bound paclitaxel

Arm Type

Experimental

Arm Description

SHR-1020 combined with albumin-bound paclitaxel

Intervention Type

Drug

Intervention Name(s)

SHR-1020+albumin-bound paclitaxel

Other Intervention Name(s)

Nab-paclitaxel， Paclitaxel-albumin

Intervention Description

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

Primary Outcome Measure Information:

Title

ORR (Objective Response Rate)

Description

Time Frame

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 Measure Information:

Title

DCR (Disease Control Rate)

Description

Time Frame

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]

Title

PFS (Progression-Free-Survival)

Description

Time Frame

From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months

Title

6mPFS

Description

Time Frame

Up to 6 months

Title

OS (overall survival)

Description

From date of treatment start to any cause death or last follow-up.

Time Frame

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

Title

Adverse events (per CTCAE v5.0 criteria)

Description

To evaluate the adverse events of patients with advanced pancreatic cancer after treated with SHR-1020 plus albumin-bound paclitaxel

Time Frame

Up to 12months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Tianjin Medical University Cancer Institute and Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

jihui Hao, MD

Phone

022-23524155

ec_tjcih@126.com

First Name & Middle Initial & Last Name & Degree

chuntao Gao, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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