Esophageal CancerPhase 1/2NCT04278287
Chemoradiotherapy in Unresectable Esophageal Cancer
A Phase 1/2 study testing Radiotherapy, Albumin-Bound Paclitaxel and Cisplatin in people with Esophageal Cancer and Chemoradiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 5 sites in China.
Trial summary
This phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Chemoradiotherapy, Albumin-bound Paxlitaxel
- What is being tested?
- Radiotherapy, Albumin-Bound Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 5 sitesChina
- Study dates
- 1 Oct 2019to Dec 2026
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18~75 years
- Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis)
- Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences
- ECOG PS score: 0~1
- NRS2002 score <3
- Estimated survival time ≥3 months
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- Normal organ and marrow function as defined below:
- Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit
- Informed consent
Who cannot join
- With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc
- Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
- Existing active infection such as active tuberculosis and hepatitis
- History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
- Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
- History of allergic reactions attributed to paclitaxel, albumin or cisplatin
- Participation in other clinical trials currently or within 4 weeks of selection
- Pregnant or lactating females
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, 455001
Xiaomin Wang, MD, shine828@163.com
- Recruiting
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, 100021
Xin Wang, MD, +861013311583220, beryl_wx2000@163.com
- Recruiting
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, 410031
Qin Xiao, MD, xiaoqin_200909@163.com
- Recruiting
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
Cheng Chen, MD
- Recruiting
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Xiaolin Ge, MD, doctorgxl@163.com
About this study
Official title: A Phase I/II Study of Chemoradiotherapy Using Albumin-Bound Paclitaxel and Cisplatin in Unresectable Esophageal Squamous Cell Carcinomas Based on Nutritional Risk Screening Score (NRS2002)
This phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.
Read the detailed description
This Phase I/II clinical study is meticulously designed to assess the one-year local tumor control rate of a chemoradiotherapy regimen that combines albumin-bound paclitaxel and cisplatin in patients with unresectable esophageal squamous cell carcinoma (ESCC). The selection of participants is guided by the Nutritional Risk Screening (NRS2002) tool, which ensures that nutritional risk factors are adequately considered and managed throughout the study.
The trial will enroll patients diagnosed with unresectable ESCC, a condition where surgical intervention is not feasible due to the tumor's location, size, or patient comorbidities. Participants will undergo a thorough nutritional assessment using the NRS2002 criteria, which evaluates factors such as weight loss, body mass index, dietary intake, and severity of disease to determine their nutritional risk score. This screening is crucial as it helps identify patients who may benefit from nutritional interventions, which could potentially improve their overall response to the treatment and quality of life.
Once enrolled, patients will receive a combination chemoradiotherapy of albumin-bound paclitaxel and cisplatin. Albumin-bound paclitaxel is chosen for its ability to improve the delivery and efficacy of paclitaxel, a chemotherapy drug, by enhancing its solubility and distribution within the body. Cisplatin, a platinum-based chemotherapy agent, is included due to its well-established efficacy in treating various cancers, including esophageal cancer. This combination aims to maximize tumor reduction while managing potential side effects.
The primary endpoint of the study is to determine the local tumor control rate at one year, which refers to the percentage of patients whose tumors have not progressed or recurred within the treated area during this period. Secondary endpoints include overall survival, progression-free survival, and assessment of treatment-related toxicity. Additionally, the study will monitor changes in patients' nutritional status and quality of life, aiming to provide comprehensive insights into the efficacy and safety of this chemoradiotherapy regimen.
Regular follow-ups and imaging studies, such as CT scans or PET scans, will be conducted to evaluate the tumor response and detect any signs of progression. Blood tests and other laboratory assessments will be performed periodically to monitor patients' overall health and manage any adverse effects promptly. The data collected from this study will contribute valuable information to the ongoing efforts to improve treatment outcomes for patients with unresectable esophageal squamous cell carcinoma.
- Conditions
- Esophageal Cancer, Chemoradiotherapy, Albumin-bound Paxlitaxel, Unresectable Malignant Neoplasm
- Being tested
- Radiotherapy, Albumin-Bound Paclitaxel, Cisplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.
Albumin-Bound PaclitaxelDrug
Also called Nab-Paclitaxel
100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.
CisplatinDrug
Also called platinum
25mg/m2 weekly,by intravenous infusion in 5-6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy | Experimental | Chemoradiotherapy arm receives intensity-modulated radiation therapy, volume modulated arc therapy or tomotherapy concurrently with albumin-bound paclitaxel and cisplatin (weekly intravenous infusion in 5-6 weeks). Receives: Radiation: Radiotherapy; Drug: Albumin-Bound Paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate
Control rate of primary esophageal cancer and metastatic lymph nodes within irradiation fields
Measured: 1 year from the start of treatment to tumor recurrence
Secondary outcomes (7)
Number of participants with acute toxicities
Acute toxicities are evaluated by NCI-CTC version 5.0
Measured: 10 week, from the start of treatment to 1 month after chemoradiotherapy
Objective response rate
Objective Response Rate are evaluated by RECIST 1.1
Measured: 5.5 week
Disease Free Survival
The time from treatment to progression or death
Measured: 1 year, 2 year
Progression Free Survival
The time from treatment to progression or death
Measured: 1 year, 2 year
Overall Survival
The time from treatment to death from any cause
Measured: 1 year, 2 year
Radiomics analysis
Radiomics analysis for tumor response and survival prediction with pre- and post-chemoradiotherapy based on MRI and CT simulation
Measured: 5.5 week
ctDNA analysis
ctDNA analysis to monitor therapeutic efficacy including tumor response and survival outcome
Measured: 4 week, 2 month, 1 year, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Oct 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIN WANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Xin Wang, MD, Principal investigator, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278287
- Sponsor's protocol ID
- 19/325-2109
- Status last verified
- Dec 2024
- First submitted
- 18 Feb 2020
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Chemoradiotherapy Using Albumin-Bound Paclitaxel and Cisplatin in Unresectable Esophageal Squamous Cell Carcinomas Based on Nutritional Risk Screening Score (NRS2002)
- ClinicalTrials.gov ID
- NCT04278287
- Acronym / sponsor ID
- 19/325-2109
- Conditions
- Esophageal Cancer, Chemoradiotherapy, Albumin-bound Paxlitaxel, Unresectable Malignant Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Feb 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 phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.
Detailed description
This Phase I/II clinical study is meticulously designed to assess the one-year local tumor control rate of a chemoradiotherapy regimen that combines albumin-bound paclitaxel and cisplatin in patients with unresectable esophageal squamous cell carcinoma (ESCC). The selection of participants is guided by the Nutritional Risk Screening (NRS2002) tool, which ensures that nutritional risk factors are adequately considered and managed throughout the study.
The trial will enroll patients diagnosed with unresectable ESCC, a condition where surgical intervention is not feasible due to the tumor's location, size, or patient comorbidities. Participants will undergo a thorough nutritional assessment using the NRS2002 criteria, which evaluates factors such as weight loss, body mass index, dietary intake, and severity of disease to determine their nutritional risk score. This screening is crucial as it helps identify patients who may benefit from nutritional interventions, which could potentially improve their overall response to the treatment and quality of life.
Once enrolled, patients will receive a combination chemoradiotherapy of albumin-bound paclitaxel and cisplatin. Albumin-bound paclitaxel is chosen for its ability to improve the delivery and efficacy of paclitaxel, a chemotherapy drug, by enhancing its solubility and distribution within the body. Cisplatin, a platinum-based chemotherapy agent, is included due to its well-established efficacy in treating various cancers, including esophageal cancer. This combination aims to maximize tumor reduction while managing potential side effects.
The primary endpoint of the study is to determine the local tumor control rate at one year, which refers to the percentage of patients whose tumors have not progressed or recurred within the treated area during this period. Secondary endpoints include overall survival, progression-free survival, and assessment of treatment-related toxicity. Additionally, the study will monitor changes in patients' nutritional status and quality of life, aiming to provide comprehensive insights into the efficacy and safety of this chemoradiotherapy regimen.
Regular follow-ups and imaging studies, such as CT scans or PET scans, will be conducted to evaluate the tumor response and detect any signs of progression. Blood tests and other laboratory assessments will be performed periodically to monitor patients' overall health and manage any adverse effects promptly. The data collected from this study will contribute valuable information to the ongoing efforts to improve treatment outcomes for patients with unresectable esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy | Experimental | Radiation: Radiotherapy, Drug: Albumin-Bound Paclitaxel, Drug: CisplatinChemoradiotherapy arm receives intensity-modulated radiation therapy, volume modulated arc therapy or tomotherapy concurrently with albumin-bound paclitaxel and cisplatin (weekly intravenous infusion in 5-6 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18~75 years
- Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis)
- Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences
- ECOG PS score: 0~1
- NRS2002 score <3
Key exclusion criteria (8 listed)
- With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc
- Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
- Existing active infection such as active tuberculosis and hepatitis
- History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
- Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
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 |
|---|---|---|
| Radiotherapy59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks. | Radiation | Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy |
| Albumin-Bound PaclitaxelAlso: Nab-Paclitaxel100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks. | Drug | Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy |
| CisplatinAlso: platinum25mg/m2 weekly,by intravenous infusion in 5-6 weeks. | Drug | Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy |
Primary outcome
Local control rate
Time frame: 1 year from the start of treatment to tumor recurrence
Control rate of primary esophageal cancer and metastatic lymph nodes within irradiation fields
7 secondary outcomes
Number of participants with acute toxicities
Time frame: 10 week, from the start of treatment to 1 month after chemoradiotherapy
Objective response rate
Time frame: 5.5 week
Disease Free Survival
Time frame: 1 year, 2 year
Progression Free Survival
Time frame: 1 year, 2 year
Overall Survival
Time frame: 1 year, 2 year
Radiomics analysis
Time frame: 5.5 week
ctDNA analysis
Time frame: 4 week, 2 month, 1 year, 2 year
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 13 Dec 2024.
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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.
Xin Wang, MD principal investigator
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiotherapy, Albumin-Bound Paclitaxel and Cisplatin in people with Esophageal Cancer and Chemoradiotherapy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 5 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 9 inclusion and 8 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 combined 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.
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 Xin Wang, MD (+861013311583220, beryl_wx2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control rate (time frame: 1 year from the start of treatment to tumor recurrence). 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 13 Dec 2024.