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

Phase 1

Recruiting

• Conditions: Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi)
• Interventions: Drug: Capecitabine, Camrelizumab

• Registration Number: NCT04932187
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-21
• Study Start: 2021-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17
• Primary Completion: 2023-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Capecitabine, Camrelizumab	Capecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w

Primary Outcome Measures

Name	Time	Method
Rate of adverse events as assessed by CTCAE v5.0	48 months

Secondary Outcome Measures

Name	Time	Method
Disease control rate	48 months
Duration of response	48 months
Overall survival	48 months
Objective response rate	48 months
Progression free survival	48 months

Trial Locations

Locations (1)

Department of Oncology, Ruijin Hospital; 🇨🇳 Shanghai, China