Nasopharyngeal CarcinomaPhase 2NCT05514275
Radiotherapy Combined With Endostatin and Capecitabine for NPC
A Phase 2 study testing Endostatin and Capecitabine in people with Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 7 sites in China.
Trial summary
Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Endostatin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 7 sitesChina
- Study dates
- 1 Aug 2022to 1 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
- Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition).
- No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) > 70. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- Adequate renal function: creatinine clearance ≥60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent.
- unsatisfactory tumor response (stable or progressive disease) after neoadjuvant chemotherapy (NACT)
Who cannot join
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
- satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Ting Jin, MD, +86-571-88128202, jinting@zjcc.org.cn
- Recruiting
the First Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
Binbin Song
- Recruiting
Jinhua Central Hospital
Jinhua, Zhejiang, 321000
Shubo Ding
- Recruiting
The Central Hospital of Lishui City
Lishui, Zhejiang, 323000
Zhifeng Tian, MD
- Recruiting
Ningbo First Hospital
Ningbo, Zhejiang, 315000
Pengrong Lou
- Recruiting
Ningbo Medical Center Lihuili Eastern Hospital
Ningbo, Zhejiang, 315000
Yi Lu
- Recruiting
People's Hospital of Quzhou
Quzhou, Zhejiang, 324000
Zheng Peng
About this study
Official title: Radiotherapy Combined With Recombinant Human Endostatin and Capecitabine for Patients With Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy
Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.
Read the detailed description
This study was a single-arm, open-label, phase II study of radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy. fourty-one patients of locally advanced NPC resistant to induction chemotherapy were enrolled. Patients received radiotherapy combined with recombinant human endostatin and capecitabine. The primary endpoint was Recurrence free survival (RFS). Secondary goals included overall survival (OS), distant metastasis-free survival (DMFS), Local-regional free survival (LRFS); adverse events (AEs) and severe adverse events (SAE); safety and quality of life (QoL).
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Endostatin and Capecitabine
- Keywords
- Nasopharyngeal Carcinoma, Radiotherapy, Endostatin, Capecitabine
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endostatin and CapecitabineDrug
Patients received radiotherapy Combined With Endostatin(37.5mg/m2, continuous intravenous infusion for 120h, D-7, D8, D22, D36) and Capecitabine( 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles)
| Study group | Role | What they receive |
|---|---|---|
| Endostatin and Capecitabine | Experimental | Patients received radiotherapy Combined With Endostatin and Capecitabine Receives: Drug: Endostatin and Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival (RFS)
calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
Measured: 3 years
Secondary outcomes (5)
overall survival (OS)
calculated from date of randomisation to death
Measured: 5 years
distant metastasis-free survival (DMFS)
calculated from date of randomisation to the first distant failure
Measured: 3 years
Local-regional free survival (LRFS)
calculated from date of randomisation to the first Local-regional failure
Measured: 3 years
adverse events (AEs) and severe adverse events (SAE)
graded according to NCI CTCAE v5.0
Measured: 5 years
quality of life (QoL)
the change of QoL from randomization to 12 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Radiotherapy Combined With Endostatin and Capecitabine
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Ting, Zhejiang Cancer Hospital
- Investigators
- Ting Jin, MD, Study chair, Department of Radiation Oncology, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514275
- Sponsor's protocol ID
- RCECNPC
- Status last verified
- Aug 2022
- First submitted
- 21 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy Combined With Recombinant Human Endostatin and Capecitabine for Patients With Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT05514275
- Acronym / sponsor ID
- RCECNPC
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Radiotherapy, Endostatin, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 24 Aug 2022 (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.
Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.
Detailed description
This study was a single-arm, open-label, phase II study of radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy. fourty-one patients of locally advanced NPC resistant to induction chemotherapy were enrolled. Patients received radiotherapy combined with recombinant human endostatin and capecitabine. The primary endpoint was Recurrence free survival (RFS). Secondary goals included overall survival (OS), distant metastasis-free survival (DMFS), Local-regional free survival (LRFS); adverse events (AEs) and severe adverse events (SAE); safety and quality of life (QoL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiotherapy Combined With Endostatin and Capecitabine
| Arm | Type | Receives |
|---|---|---|
| Endostatin and Capecitabine | Experimental | Drug: Endostatin and CapecitabinePatients received radiotherapy Combined With Endostatin and Capecitabine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
- Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition).
- No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) > 70. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- Adequate renal function: creatinine clearance ≥60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent.
Key exclusion criteria (5 listed)
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
- satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)
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 |
|---|---|---|
| Endostatin and CapecitabinePatients received radiotherapy Combined With Endostatin(37.5mg/m2, continuous intravenous infusion for 120h, D-7, D8, D22, D36) and Capecitabine( 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles) | Drug | Endostatin and Capecitabine |
Primary outcome
Recurrence free survival (RFS)
Time frame: 3 years
calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
5 secondary outcomes
overall survival (OS)
Time frame: 5 years
distant metastasis-free survival (DMFS)
Time frame: 3 years
Local-regional free survival (LRFS)
Time frame: 3 years
adverse events (AEs) and severe adverse events (SAE)
Time frame: 5 years
quality of life (QoL)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Ting Jin, MD study chair
Department of Radiation Oncology, Zhejiang Cancer Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endostatin and Capecitabine in people with Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 7 sites 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Jin, MD (+86-571-88128202, jinting@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (RFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2022.