Refractory or Metastatic Esophageal Squamous Cell CarcinomaPhase 2NCT03320629
A Study of Apatinib Plus Radiotherapy and S-1 for Treatment of Refractory or Metastatic Esophageal Squamous Cell Carcinoma
A Phase 2 study testing apatinib S-1 radiotherapy and S-1 radiotherapy in people with Refractory or Metastatic Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus radiotherapy and S-1 for treatment of refractory or metastatic esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory or Metastatic Esophageal Squamous Cell Carcinoma
- What is being tested?
- apatinib S-1 radiotherapy and S-1 radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 31 Dec 2018
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age:18 to 70 years old (man or female); 2. Imageology diagnosed with refractory or metastatic esophageal squamous cell carcinoma(pathologically diagnosed with supraclavicular lymph node metastasis and anastomotic recurrence ); 3. The distant metastatic is oligotransfera, with radiotherapy indication; 4. Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Major organ function has to meet the following certeria:
- For results of blood routine test (without blood transfusion within 14 days)
- HB≥100g/L;
- ANC≥3.0×109/L;
- PLT≥100×109/L;
- For results of blood biochemical test：
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- TBIL<1.5×ULN；
- ALT and AST<2.5×ULN, but< 5×ULN if the transferanse elevation is due to liver metastases；
- Serum creatinine ≤1ULN , calculated creatinine clearance>50 ml/min(per the Cockcroft-Gault formula); 7. Life expectancy greater than or equal to 3 months; 8. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 9. Coagulation function is normal, without active hemorrhage and thrombosis:
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- INR<1.5×ULN
- APTT<1.5×ULN
- PT<1.5ULN 10. Participants were willing to join in this study, and written informed consent; 11. Participants were good adherence, cooperate with the follow-up.
Who cannot join
- 1. Allergic to apatinib; 2. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with classⅡand above coronary heart disease and arrhythmia (including QTc lengthened men > 450 ms, women > 470 ms) and cardiac insufficiency; 3. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 4. Patients with tendency of gastrointestinal bleeding, including the following;
- Active ulcerative lesions, and defecate occult blood (+ +);
- Has melena and hematemesis in three months;
- For defecate occult blood (+) or(+/-) ,must be received gastroscopy, the physicians consider there are potential bleeding risk with ulcers, hemorrhagic diseases; 5. Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency; 6. Patients with thrombosis or anticoagulant drug therapy; 7. Patients with symptoms of central nervous system metastasis; Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ); 8. history of psychiatric drugs abuse and can't quit or patients with mental disorders; 9. Less than 4 weeks from the last clinical trial; 10. Have received prior treatment with anti- VEGF/VEGFR; 11. Researchers considered there are serious harm to patient safety or affect the patients who have completed the study; 12. Pregnant or lactating women; 13. The researchers think inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of Apatinib Plus Radiotherapy and S-1 for Treatment of Refractory or Metastatic Esophageal Squamous Cell Carcinoma
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus radiotherapy and S-1 for treatment of refractory or metastatic esophageal squamous cell carcinoma.
- Being tested
- apatinib S-1 radiotherapy, S-1 radiotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinib S-1 radiotherapyCombination product
apatinib 500mg qd po S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent
S-1 radiotherapyCombination product
S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent
| Study group | Role | What they receive |
|---|---|---|
| apatinib and S-1 radiotherapy | Experimental | apatinib 500mg qd po S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Combination Product: apatinib S-1 radiotherapy |
| S-1 radiotherapy | Active comparator | S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Combination Product: S-1 radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Baseline to measured date of progression or death from any cause
Measured: evaluated in 24 months since the treatment began
Secondary outcomes (4)
Overall survival
Baseline to measured date of death from any cause
Measured: the first day of treatment to death or last survival confirm date，up to 24 months
Disease control rate
Baseline to measured progressive disease
Measured: tumor assessment every 6 weeks ，up to 24 month
Objective response rate
Baseline to measured stable disease
Measured: tumor assessment every 6 weeks，up to 24 months
Side effects
throughout study
Measured: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Nov 2017
- Primary completion1 Nov 2017
- Study completion31 Dec 2018
Why it stopped: This study was voluntarily terminated after investigator assessment, with no safety concerns identified related to the trial intervention or procedures. The primary reason for termination was difficulty in patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory or Metastatic Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun wang, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320629
- Sponsor's protocol ID
- HRA-E01
- Status last verified
- Oct 2017
- First submitted
- 20 Oct 2017
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Apatinib Plus Radiotherapy and S-1 for Treatment of Refractory or Metastatic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03320629
- Acronym / sponsor ID
- HRA-E01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was voluntarily terminated after investigator assessment, with no safety concerns identified related to the trial intervention or procedures. The primary reason for termination was difficulty in patient recruitment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 Oct 2017 (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.
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus radiotherapy and S-1 for treatment of refractory or metastatic esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apatinib and S-1 radiotherapy | Experimental | Combination Product: apatinib S-1 radiotherapyapatinib 500mg qd po S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent |
| S-1 radiotherapy | Active comparator | Combination Product: S-1 radiotherapyS-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Age:18 to 70 years old (man or female); 2. Imageology diagnosed with refractory or metastatic esophageal squamous cell carcinoma(pathologically diagnosed with supraclavicular lymph node metastasis and anastomotic recurrence ); 3. The distant metastatic is oligotransfera, with radiotherapy indication; 4. Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 6. Major organ function has to meet the following certeria:
- <!-- -->
Key exclusion criteria (4 listed)
- 1. Allergic to apatinib; 2. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with classⅡand above coronary heart disease and arrhythmia (including QTc lengthened men > 450 ms, women > 470 ms) and cardiac insufficiency; 3. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 4. Patients with tendency of gastrointestinal bleeding, including the following;
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 |
|---|---|---|
| apatinib S-1 radiotherapyapatinib 500mg qd po S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent | Combination product | apatinib and S-1 radiotherapy |
| S-1 radiotherapyS-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent | Combination product | S-1 radiotherapy |
Primary outcome
Progression free survival
Time frame: evaluated in 24 months since the treatment began
Baseline to measured date of progression or death from any cause
4 secondary outcomes
Overall survival
Time frame: the first day of treatment to death or last survival confirm date，up to 24 months
Disease control rate
Time frame: tumor assessment every 6 weeks ，up to 24 month
Objective response rate
Time frame: tumor assessment every 6 weeks，up to 24 months
Side effects
Time frame: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Results and safety
The study was stopped early (reason given: This study was voluntarily terminated after investigator assessment, with no safety concerns identified related to the trial intervention or procedures. The primary reason for termination was difficulty in patient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing apatinib S-1 radiotherapy and S-1 radiotherapy in people with Refractory or Metastatic Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth 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 13 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Aug 2025. 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 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?
The study was stopped early (reason given: This study was voluntarily terminated after investigator assessment, with no safety concerns identified related to the trial intervention or procedures. The primary reason for termination was difficulty in patient recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: evaluated in 24 months since the treatment began). 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 6 Aug 2025.