NCT05185869

Brief Summary

The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic pancreatic cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P50-P75 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 11, 2022

Status Verified

October 1, 2021

Enrollment Period

3.5 years

First QC Date

December 19, 2021

Last Update Submit

January 10, 2022

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • Objective Response Rate (ORR)

    ORR is defined as the proportion of patients with best objective response of confirmed complete response (CR) or partial response (PR) according to RECIST1.1.

    Up to 2 years.

  • Adverse Events (AEs)

    AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

    From the first drugs administration to within 30 days for the last treatment.

Secondary Outcomes (3)

  • Overall Survival (OS)

    Up to 2 years.

  • Progression Free Survival (PFS)

    Up to 2 years.

  • Disease Control Rate (DCR)

    Up to 2 years.

Study Arms (1)

AG+SHR6390

EXPERIMENTAL

Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine

Drug: SHR6390Drug: Nab-paclitaxelDrug: Gemcitabine

Interventions

SHR6390DRUG

SHR6390, Oral Administration

AG+SHR6390
Nab-paclitaxelDRUG

Paclitaxel-albumin, Intravenous Injection

AG+SHR6390
GemcitabineDRUG

Gemcitabine, Intravenous Injection

AG+SHR6390

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female of 18 to 75 years old;
  • Subjects are diagnosed with histologically confirmed unresectable advanced or metastatic pancreatic ductal adenocarcinoma with at least one measurable lesion according to the RECIST 1.1 standard (the CT scan length of the tumor lesion \> 10 mm);
  • Subjects are naïve to systemic treatment;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  • Life expectancy ≥12 weeks;
  • Adequate organ performance based on laboratory blood tests;
  • The toxicity of the previous treatment has been restored to ≤1 level (if there is surgery, the wound has completely healed);
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
  • Normal swallowing function;
  • 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:

  • Had other active malignant tumors within 5 years before entering the study;
  • Confirmed or suspicious new metastatic lesion in brain;
  • Subjects are allergy to experimental drugs or any excipients;
  • Coagulation disorders (INR\>1.5, APTT\>ULN);
  • Severe pleural effusion or ascites;
  • Severe and uncontrolled medical diseases, acute infections; recent history of major surgery for myocardial infarction (within 3 months);
  • Subjects combined with other anti-tumor drugs;
  • Chronic diarrhea or intestinal obstruction;
  • Pregnant or lactating women; Fertile subjects who are unwilling or unable to take effective contraceptive measures;
  • Subjects in any trial drug treatment;
  • Severe mental disorder;
  • Other situations that investigators considered should be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxelGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Baiyong Shen, Ph.D&M.D

CONTACT

008613901943778shenby@shsmu.edu.cn

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

December 19, 2021

First Posted

January 11, 2022

Study Start

January 1, 2022

Primary Completion

July 1, 2025

Study Completion

October 1, 2025

Last Updated

January 11, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)