Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 1)

Advanced Cervical Cancer Clinical Trial

Official title:

Phase 1 Trail to Observe Safety and Efficacy of Metronomic Capecitabine Plus PD-L1 Antibody Camrelizumab as Third-line Regimen to Treat HER2 Negative Advanced Gastric Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04508686
• Other study ID #: McCrest
• Status: Recruiting
• Phase: Phase 1
• Start date: August 1, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2021
• Source: Ruijin Hospital
• Contact: Jing Liu
• Phone: +86-18001753364
• Email: liujing23[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single center phase 1 trail to observe safety and efficacy of metronomic capecitabine plus PD-L1 antibody camrelizumab as third-line regimen to treat HER2 negative advanced gastric 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.

Description:

HER2 negative advanced gastric cancer patients who have disease progression after two 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male/female patients aged=18 years.

2. Histologically confirmed gastric or gastric esophageal junction adenocarcinoma, without uncontrolled pleural effusion or ascites.

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

4. HER2 negative, 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.

Related Conditions & MeSH terms

• Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Capecitabine, camrelizumab
This is a single-arm study with all patients receiving these two drugs.

Locations

Country	Name	City	State
China	Department of Oncology, Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: adverse events as assessed by CTCAE v5.0		48 months
Secondary	Progression free survival		48 months
Secondary	Overall survival		48 months
Secondary	Objective response rate		48 months
Secondary	Disease control rate		48 months
Secondary	Duration of response		48 months