NCT04324307

Brief Summary

To evaluate the efficacy of PD-L1/CTLA4 BsAb for the second line treatment and the combination with chemotherapy for the first line treatment in 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
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2019

Longer than P75 for phase_1

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

Study Start

First participant enrolled

November 26, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

3.9 years

First QC Date

January 25, 2020

Last Update Submit

August 31, 2023

Conditions

Locally Advanced and Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • ORR

    objective response rate

    2 years

Secondary Outcomes (5)

  • DCR

    2 years

  • DOR

    2 years

  • TTP

    2 years

  • PFS

    2 years

  • OS

    2 years

Study Arms (3)

PD-L1/CTLA4 BsAb

EXPERIMENTAL

For 2nd line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W

Drug: PD-L1/CTLA4 BsAb

PD-L1/CTLA4 BsAb + GP

EXPERIMENTAL

For 1st line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Gemcitabine 1000 mg/m2 and Nab-paclitaxel 125 mg/m2 , 28days/cycle

Drug: PD-L1/CTLA4 BsAbCombination Product: GP

PD-L1/CTLA4 BsAb + FOLFIRINOX

EXPERIMENTAL

For 1st line treatment，PD-L1/CTLA4 BsAb 5mg/kg Q2W in combination with Oxaliplatin 68 or 85 mg/m2, Irinotecan 135 or 150 or 180 mg/m2, Calcium Folate 400 mg/m2, Fluorouracil 2400mg/m2, 14 days/cycle

Drug: PD-L1/CTLA4 BsAbCombination Product: FOLFIRINOX

Interventions

PD-L1/CTLA4 BsAbDRUG

PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W

PD-L1/CTLA4 BsAbPD-L1/CTLA4 BsAb + FOLFIRINOXPD-L1/CTLA4 BsAb + GP
GPCOMBINATION_PRODUCT

Gemcitabine 1000mg/m2, iv, D1,8,15, 28days/cycle; nab-Paclitaxel 125mg/m2，iv，D1,8,15, 28days/cycle;

Also known as: Gemcitabine, nab-Paclitaxel
PD-L1/CTLA4 BsAb + GP
FOLFIRINOXCOMBINATION_PRODUCT

Fluorouracil 2400mg/m2，iv，D1, 14days/cycle; Oxaliplatin 68-85mg/m2，iv, D1,14days/cycle;Irinotecan135-180mg/m2，iv, D1, 14days/cycle;Calcium Folate 400mg/m2，iv, D1, 14days/cycle;

Also known as: Oxaliplatin, Irinotecan, Calcium Folate, Fluorouracil
PD-L1/CTLA4 BsAb + FOLFIRINOX

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histology or cytology confirmed as pancreatic ductal adenocarcinoma;
  • ECOG 0-1;
  • adequate organ function (absolute neutrophil count ≥1.5 x 109/L; platelet count ≥100 x 109/L; creatinine \< 1.5 x ULN (upper normal) or calculated creatinine clearance ( CRCI) ≥ 60mL/min; albumin ≥ 30g/L; total bilirubin \<1.5 x ULN; aspartate aminotransferase (AST) \< 2.5 x ULN; alanine aminotransferase (ALT) \< 2.5x ULN; INR or PT \< 1.5x ULN, and aPTT \<1.5x ULN);
  • no obvious symptoms of jaundice and ascites;
  • no other serious underlying diseases

You may not qualify if:

  • patients with active brain metastases;
  • history of autoimmune diseases, or need to be treated with corticosteroids and immunosuppressive agents;
  • past history of unstable angina, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction within 6 months, QT interval prolongation (\>450ms);
  • other malignant tumors within the last 5 years;
  • pregnant or lactating women;
  • NRS ≥ 4 points;
  • unintentional weight loss ≥ 5% within 1 month before the first dose even if peripheral or central vein nutrition support,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine130-nm albumin-bound paclitaxelfolfirinoxOxaliplatinIrinotecanFluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsUracilPyrimidinones

Study Officials

  • Gang Jin, Doctor

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiwei Guo, Doctor

CONTACT

86-18621500666gestwa@163.com

Suizhi Gao, Doctor

CONTACT

86-13167137990gaosuizhi@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 25, 2020

First Posted

March 27, 2020

Study Start

November 26, 2019

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

CN(1)