Clinical trial · Interventional
Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 2)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cancer | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, Camrelizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Capecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w
- interventionNames
- Drug: Capecitabine, Camrelizumab
Primary outcomes (1)
- measure
- Rate of adverse events as assessed by CTCAE v5.0
- timeFrame
- 48 months
Secondary outcomes (5)
- measure
- Progression free survival
- timeFrame
- 48 months
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZhou C, Yin Y, Shangguan C, Wu Q, Cai Q, Xi W, Guo L, Jiang J, Shi M, Wu J, Ji J, Zhang X, Sun Y, Rensen SSM, Damink SWMO, Zhu Z, Zeng R, Zhang J. Lipid metabolism associated with efficacy of metronomic capecitabine and camrelizumab in gastrointestinal cancer: an exploratory clinical trial. BMC Med. 2025 Oct 21;23(1):572. doi: 10.1186/s12916-025-04377-4. PMID 41121239