Clinical Trials /

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

NCT04932187

Description:

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.

Related Conditions:
  • Cholangiocarcinoma
  • Digestive System Carcinoma
  • Pancreatic Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: McCrest-3
  • NCT ID: NCT04932187

Conditions

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

Interventions

DrugSynonymsArms
Capecitabine, CamrelizumabExperimental

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
ExperimentalExperimentalCapecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w
  • Capecitabine, Camrelizumab

Eligibility Criteria

        Inclusion Criteria:

          1. Male/female patients aged≥18 years.

          2. Histologically confirmed hepatobiliary, pancreatic and other gastrointestinal
             carcinoma (non-stomach, non-esophagi), without uncontrolled pleural effusion or
             ascites.

          3. Patients with advanced or metastatic disease who have disease progression after all
             standard regimens, with measurable or unmeasurable lesions.

          4. MSS or pMMR.

          5. ECOG performance status 0 or 2, expected lifetime≥3 months.

          6. 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.

          7. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV
             DNA<500IU/ml (or 2500 copies/ml).

          8. Pregnancy test of female patients with fertile activity should be negative within 7
             days before enrollment. Patients should keep contraception during treatment.

          9. 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:

          1. Pregnancy or children bearing potential.

          2. Brain or meningeal metastasis.

          3. With second primary malignant diseases.

          4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or
             patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).

          5. With uncontrollable complications

          6. Inadequate organ function

          7. Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel
             obstruction).

          8. known hypersensitivity reaction to any of the study drugs or components.

          9. Other unsuitable conditions determined by investigators.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Rate of adverse events as assessed by CTCAE v5.0
Time Frame:48 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression free survival
Time Frame:48 months
Safety Issue:
Description:
Measure:Overall survival
Time Frame:48 months
Safety Issue:
Description:
Measure:Objective response rate
Time Frame:48 months
Safety Issue:
Description:
Measure:Disease control rate
Time Frame:48 months
Safety Issue:
Description:
Measure:Duration of response
Time Frame:48 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ruijin Hospital

Last Updated

June 21, 2021