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Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 3)

Primary Purpose

Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi)

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Capecitabine, Camrelizumab

About this trial

This is an interventional treatment trial for Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi)

Eligibility Criteria

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

Inclusion Criteria:

Male/female patients aged≥18 years.
Histologically confirmed hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi), without uncontrolled pleural effusion or ascites.
Patients with advanced or metastatic disease who have disease progression after all standard regimens, with measurable or unmeasurable lesions.
MSS or pMMR.
ECOG performance status 0 or 2, expected lifetime≥3 months.
Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml).
Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

Exclusion Criteria:

Pregnancy or children bearing potential.
Brain or meningeal metastasis.
With second primary malignant diseases.
With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).
With uncontrollable complications
Inadequate organ function
Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
known hypersensitivity reaction to any of the study drugs or components.
Other unsuitable conditions determined by investigators.

Sites / Locations

Department of Oncology, Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Capecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w

Outcomes

Primary Outcome Measures

Rate of adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Progression free survival

Overall survival

Objective response rate

Disease control rate

Duration of response

Full Information

NCT ID

NCT04932187

First Posted

June 17, 2021

Last Updated

September 16, 2021

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04932187

Brief Title

Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 3)

Official Title

Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor (McCrest) Trial: Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi) (Cohort 3)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin 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 is a single center phase 1 trial to observe safety and efficacy of metronomic capecitabine plus PD-L1 antibody camrelizumab to treat hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all standard regimens. This study is one of the cohorts of a multi-cohort trial called Combination of Metronomic capecitabine with Camrelizumab for treatment of refractory solid tumor (McCrest) trial.

Detailed Description

Hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all standard regimens will be treated by metronomic capecitabine plus camrelizumab. Metronomic capecitabine will be given as fixed dose (500mg bid) orally. Camrelizumab will be given two-weekly (200mg once) intravenously. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.

6. Conditions and Keywords

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

Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Capecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w

Intervention Type

Drug

Intervention Name(s)

Capecitabine, Camrelizumab

Intervention Description

This is a single-arm study with all patients receiving these two drugs.

Primary Outcome Measure Information:

Title

Rate of adverse events as assessed by CTCAE v5.0

Time Frame

48 months

Secondary Outcome Measure Information:

Title

Progression free survival

Time Frame

48 months

Title

Overall survival

Time Frame

48 months

Title

Objective response rate

Time Frame

48 months

Title

Disease control rate

Time Frame

48 months

Title

Duration of response

Time Frame

48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male/female patients aged≥18 years. Histologically confirmed hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi), without uncontrolled pleural effusion or ascites. Patients with advanced or metastatic disease who have disease progression after all standard regimens, with measurable or unmeasurable lesions. MSS or pMMR. ECOG performance status 0 or 2, expected lifetime≥3 months. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml). Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form. Exclusion Criteria: Pregnancy or children bearing potential. Brain or meningeal metastasis. With second primary malignant diseases. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone). With uncontrollable complications Inadequate organ function Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction). known hypersensitivity reaction to any of the study drugs or components. Other unsuitable conditions determined by investigators.

Central Contact Person:

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

Min Shi, MD & Ph. D

Phone

+86-21-64370045

sm11998@rjh.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Zhang, MD & Ph. D

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, Ruijin Hospital

City

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Zhang, MD & Ph. D

Phone

+86-13818332497

junzhang10977@sjtu.edu.cn

First Name & Middle Initial & Last Name & Degree

Jun Zhang, MD & Ph. D

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 3)

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