Back to results

Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

Primary Purpose

Locally Advanced and Metastatic Pancreatic Cancer

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

PD-L1/CTLA4 BsAb

FOLFIRINOX

About this trial

This is an interventional treatment trial for Locally Advanced and Metastatic Pancreatic Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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,

Sites / Locations

Changhai hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

PD-L1/CTLA4 BsAb

PD-L1/CTLA4 BsAb + GP

PD-L1/CTLA4 BsAb + FOLFIRINOX

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

ORR

objective response rate

Secondary Outcome Measures

DCR

Disease Control Rate

DOR

Duration of Response

TTP

Time to Response

PFS

Progression Free Survival

Overall Survival

Full Information

NCT ID

NCT04324307

First Posted

January 25, 2020

Last Updated

August 31, 2023

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04324307

Brief Title

Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

Official Title

Multicenter, Open-label Clinical Study of PD-L1/CTLA4 BsAb Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 26, 2019 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

Subjects who signed the informed consent were assigned to three cohorts according to the actual treatment status. Cohort 1 enrolled subjects receiving PD-L1/CTLA4 BsAb 5mg/kg iv Q2W for 2nd treatment; cohort 2 enrolled subjects receiving PD-L1/CTLA4 BsAb in combination with gemcitabine/albumin- paclitaxel as 1st treatment for 4-6 cycles with PD-L1/CTLA4 BsAb monotherapy maintainence; cohort 3 enrolled subjects received systemic chemotherapy, receiving PD-L1/CTLA4 BsAb combined with oxaliplatin / irinotecan / leucovorin / fluorouracil (FOLFIRINOX) as 1st treatment for 4-6 cycles withPD-L1/CTLA4 BsAb monotherapy maintainence; until disease progression according to RECIST 1.1, intolerable toxicity, withdrawal, death, 2-yr treatment,who comes first.

6. Conditions and Keywords

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

Locally Advanced and Metastatic Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PD-L1/CTLA4 BsAb

Arm Type

Experimental

Arm Description

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

Arm Title

PD-L1/CTLA4 BsAb + GP

Arm Type

Experimental

Arm Description

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

Arm Title

PD-L1/CTLA4 BsAb + FOLFIRINOX

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

PD-L1/CTLA4 BsAb

Intervention Description

PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W

Intervention Type

Combination Product

Intervention Name(s)

Other Intervention Name(s)

Gemcitabine, nab-Paclitaxel

Intervention Description

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

Intervention Type

Combination Product

Intervention Name(s)

FOLFIRINOX

Other Intervention Name(s)

Oxaliplatin, Irinotecan, Calcium Folate, Fluorouracil

Intervention Description

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;

Primary Outcome Measure Information:

Title

ORR

Description

objective response rate

Time Frame

2 years

Secondary Outcome Measure Information:

Title

DCR

Description

Disease Control Rate

Time Frame

2 years

Title

DOR

Description

Duration of Response

Time Frame

2 years

Title

TTP

Description

Time to Response

Time Frame

2 years

Title

PFS

Description

Progression Free Survival

Time Frame

2 years

Title

Description

Overall Survival

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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,

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shiwei Guo, Doctor

Phone

86-18621500666

gestwa@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Suizhi Gao, Doctor

Phone

86-13167137990

gaosuizhi@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Jin, Doctor

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changhai hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shiwei Guo, Doctor

Phone

86-18621500666

gestwa@163.com

12. IPD Sharing Statement

Learn more about this trial

Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

We'll reach out to this number within 24 hrs