Head and Neck CancerPhase 1NCT04510818
Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 2)
A Phase 1 study testing Capecitabine, Camrelizumab in people with Head and Neck Cancer and Esophageal Squamous Cancer, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Esophageal Squamous Cancer
- What is being tested?
- Capecitabine, Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female patients aged≥18 years.
- Histologically confirmed Head and neck cancer or Esophageal squamous cancer, without uncontrolled pleural effusion or ascites.
- Patients with advanced or metastatic disease who have disease progression after first standard regimen, with measurable or unmeasurable lesions.
- MSS or pMMR.
- ECOG performance status 0 to 2, expected lifetime≥3 months.
- 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.
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- HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA<500IU/ml (or 2500 copies/ml).
- Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
- 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.
Who cannot join
- Pregnancy or children bearing potential.
- brain or meningeal metastasis.
- With second primary malignant diseases.
- With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).
- With uncontrollable complications
- Inadequate organ function
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- Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
- known hypersensitivity reaction to any of the study drugs or components.
- Other unsuitable conditions determined by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oncology, Ruijin Hospital
Shanghai, 200025
Jun Zhang, MD & Ph. D, +86-13818332497, junzhang10977@sjtu.edu.cn
Jun Zhang, MD & Ph. D
About this study
Official title: 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 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.
Read the detailed description
Head and neck cancer / Esophageal squamous cancer patients who have disease progression after first standard regimen 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.
- Conditions
- Head and Neck Cancer, Esophageal Squamous Cancer
- Being tested
- Capecitabine, Camrelizumab
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine, CamrelizumabDrug
This is a single-arm study with all patients receiving these two drugs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Capecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w Receives: Drug: Capecitabine, Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events as assessed by CTCAE v5.0
Measured: 48 months
Secondary outcomes (5)
Progression free survival
Measured: 48 months
Overall survival
Measured: 48 months
Objective response rate
Measured: 48 months
Disease control rate
Measured: 48 months
Duration of response
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Aug 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Ruijin Hospital
- Investigators
- Jun Zhang, MD & Ph. D, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510818
- Sponsor's protocol ID
- McCrest-2
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou 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.
PubMed 41121239
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04510818
- Acronym / sponsor ID
- McCrest-2
- Conditions
- Head and Neck Cancer, Esophageal Squamous Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Head and neck cancer / Esophageal squamous cancer patients who have disease progression after first standard regimen 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Capecitabine, CamrelizumabCapecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male/female patients aged≥18 years.
- Histologically confirmed Head and neck cancer or Esophageal squamous cancer, without uncontrolled pleural effusion or ascites.
- Patients with advanced or metastatic disease who have disease progression after first standard regimen, with measurable or unmeasurable lesions.
- MSS or pMMR.
- ECOG performance status 0 to 2, expected lifetime≥3 months.
Key exclusion criteria (9 listed)
- Pregnancy or children bearing potential.
- brain or meningeal metastasis.
- With second primary malignant diseases.
- With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (>10mg/d prednisone).
- With uncontrollable complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine, CamrelizumabThis is a single-arm study with all patients receiving these two drugs. | Drug | Experimental |
Primary outcome
Rate of adverse events as assessed by CTCAE v5.0
Time frame: 48 months
5 secondary outcomes
Progression free survival
Time frame: 48 months
Overall survival
Time frame: 48 months
Objective response rate
Time frame: 48 months
Disease control rate
Time frame: 48 months
Duration of response
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Derived from this study: PubMed 41121239Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Zhang, MD & Ph. D principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capecitabine, Camrelizumab in people with Head and Neck Cancer and Esophageal Squamous Cancer, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Liu (+86-18001753364, liujing23@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse events as assessed by CTCAE v5.0 (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04510818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.