Overview

Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 2)

Status:
Recruiting
Trial end date:
2024-08-01
Target enrollment:
0
Participant gender:
All
Summary
This is a single center phase 1 trail to observe safety and efficacy of metronomic Capecitabine plus Camrelizumab as second-line regimen to treat head and neck cancer or esophageal squamous cancer patients. 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ruijin Hospital
Treatments:
Capecitabine
Criteria
Inclusion Criteria:

1. Male/female patients aged≥18 years.

2. Histologically confirmed Head and neck cancer or Esophageal squamous cancer, without
uncontrolled pleural effusion or ascites.

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

4. MSS or pMMR.

5. ECOG performance status 0 to 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.