Esophageal CancerNCT04822103
A Real-World Study of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer
An observational study of Esophageal Cancer, run by Guangdong Provincial People's Hospital at 2 sites in China.
Trial summary
The role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- How many people
- 155 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2021to 31 Oct 2021
- Phase
- Observational
- 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
Study population: Patients diagnosed as potentially resectable (including initially-unresectable) esophageal squamous cell carcinoma via pathological specimen, KPS ≥ 80, has adequate organ function and no distant metastasis are included in the study
Who may be able to join
- Pathologically diagnosed as esophageal squamous cell carcinoma
- KPS≥80
- Adequate organ function
- No distant metastasis
- The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist
Who cannot join
- incomplete medical record which affects statistical analysis
- have participated in previous interventional clinical trials
- other situations evaluated by investigators not meet the enrollment
Trial locations and contacts
2 sites in 1 country.
China2 sites
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Shantou Central Hospital
Shantou, Guangdong, 515031
About this study
Official title: A Real-World Study Evaluating the Effectiveness and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer
The role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, real-world study, immunotherapy, chemotherapy
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate
Measured: Up to 24 weeks
Safety as measured by number of participants with Grade 3 and 4 adverse events
Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0
Measured: Up to 12 weeks
Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses
The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses.
Measured: Up to 36 weeks
Secondary outcomes (5)
Pathologic complete response rate (pCR)
The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery
Measured: Three to five working days after surgery
R0 resection rate
The R0 resection rate of esophagectomy
Measured: Three to five working days after surgery
Overall survival
Overall survival rate
Measured: from the date of diagnosis to the date of death, assessed up to 100 months
Event-free survival
EFS
Measured: from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months
Major pathological response
≤10% residual viable tumor follow NAIC
Measured: Three to five working days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Jan 2021
- Primary completion1 Oct 2021
- Study completion31 Oct 2021
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 Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The People's Hospital of Gaozhou, The General Hospital of Southern Theater Command, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, First Affiliated Hospital of Shantou University Medical College, First Affiliated Hospital, Sun Yat-Sen University, Shantou Central Hospital, Shenzhen People's Hospital
- Responsible party
- Sponsor
- Investigators
- Guibin Qiao, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822103
- Sponsor's protocol ID
- RICE-retro
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang W, Ma SC, Fang Z, Liu Y, Zhang X, Wang F, Wang C, Wang Y, Wang X, Chen W, Luo H, Yang L, Zhang S, Zeng B, Liu Z, Ou Q, Cai J, Yeung SJ, Cheng C. TP53-centric ctDNA complements PET/CT for non-invasive assessment of pathological complete response and survival after neoadjuvant immunochemotherapy in esophageal squamous cell carcinoma: a prospective cohort study. Int J Surg. 2025 May 1;111(5):3256-3268. doi: 10.1097/JS9.0000000000002341.
PubMed 40146232
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study Evaluating the Effectiveness and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT04822103
- Acronym / sponsor ID
- RICE-retro
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, real-world study, immunotherapy, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- The People's Hospital of Gaozhou, The General Hospital of Southern Theater Command, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, First Affiliated Hospital of Shantou University Medical College, First Affiliated Hospital, Sun Yat-Sen University, Shantou Central Hospital, Shenzhen People's Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 30 Mar 2021 (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 role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as potentially resectable (including initially-unresectable) esophageal squamous cell carcinoma via pathological specimen, KPS ≥ 80, has adequate organ function and no distant metastasis are included in the study
Key inclusion criteria (5 listed)
- Pathologically diagnosed as esophageal squamous cell carcinoma
- KPS≥80
- Adequate organ function
- No distant metastasis
- The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist
Key exclusion criteria (3 listed)
- incomplete medical record which affects statistical analysis
- have participated in previous interventional clinical trials
- other situations evaluated by investigators not meet the enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 24 weeks
Objective Response Rate
Safety as measured by number of participants with Grade 3 and 4 adverse events
Time frame: Up to 12 weeks
Number of Grade 3 and 4 adverse events as defined by CTCAE v5.0
Feasibility of immunochemotherapy defined as at least 80% of the patients completed all planned courses
Time frame: Up to 36 weeks
The feasibility of immunochemotherapy was defined as at least 80% of the patients completed all planned courses.
5 secondary outcomes
Pathologic complete response rate (pCR)
Time frame: Three to five working days after surgery
R0 resection rate
Time frame: Three to five working days after surgery
Overall survival
Time frame: from the date of diagnosis to the date of death, assessed up to 100 months
Event-free survival
Time frame: from the date of treatment initiation to the date of first progression (local recurrence of tumor or distant metastasis) or death from any cause, assessed up to 100 months
Major pathological response
Time frame: Three to five working days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 40146232Yang W, Ma SC, Fang Z, Liu Y, Zhang X, Wang F, Wang C, Wang Y, Wang X, Chen W, Luo H, Yang L, Zhang S, Zeng B, Liu Z, Ou Q, Cai J, Yeung SJ, Cheng C. TP53-centric ctDNA complements PET/CT for non-invasive assessment of pathological complete response and survival after neoadjuvant immunochemotherapy in esophageal squamous cell carcinoma: a prospective cohort study. Int J Surg. 2025 May 1;111(5):3256-3268. doi: 10.1097/JS9.0000000000002341.
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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.
Guibin Qiao, MD principal investigator
Guangdong Provincial People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Guangdong Provincial People's Hospital at 2 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective Response Rate (ORR) (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. 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 NCT04822103, 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 18 Mar 2022.