Esophageal Squamous Cell CarcinomaPhase 2PICCRTNCT05596890
Patient-reported Outcomes in Preoperative Immunochemotherapy/Radiotherapy-treated Esophageal Cancer Patients
A Phase 2 study testing Paclitaxel-albumin, Cisplatin and Carboplatin in people with Esophageal Squamous Cell Carcinoma and Patient-reported Outcomes, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Preoperative Immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. However, there are still a significant proportion of patients who could not benefit from such treatment modality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Patient-reported Outcomes, Immunotherapy
- What is being tested?
- Paclitaxel-albumin, Cisplatin and Carboplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2022to 30 Sep 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed esophageal squamous cell carcinoma
- Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4aN1-2M0, cT3-T4aN0M0)
- Treatment-naive
- Expected life span > 6 months
- Aged 18 - 75 years old
- Adequate organ functions
- PS 0-2
- Participants are fully informed about the whole study and are willing to sign the informed consent
Who cannot join
- Previous history of thoracic surgery or radiation
- Cervical or multi-origin esophageal cancer
- Known or suspected experimental drug allergy
- Pregnant or lactating women
- Esophagomediastianl fistula
- Peripheral neuropathy
Show all 13Show fewer
- Previous cancer history other than esophageal cancer
- Severe organ function deterioration that can not tolerate neoadjuvant therapy
- Previous autoimmune diseases
- diabetic history > 10 years
- interstitial pulmonary disease, non-infectious pulmonitis
- Active type B hepatitis
- Any other conditions that may affect patients' safety and compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Guibin Qiao, MD, 13602749153, guibinqiao@126.com
Songxi Xie
About this study
Official title: Patient-reported Outcome-based Surveillance System Evaluating Safety and Efficacy of Preoperative Immunochemotherapy +/- Chemoradiation in Patients With Esophageal Squamous Cell Carcinoma - A Prospective, Explorative, Phase II Study
Preoperative Immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. However, there are still a significant proportion of patients who could not benefit from such treatment modality. Currently, no effective biomarkers were identified to stratify responders and non-responders. Early dynamic and persistent relief of dysphagia may act as a predictive biomarker to reflect the on-treatment anti-tumor activity. In this prospective study, we aimed to explore the feasibility of using patient-reported outcomes (PROs) to predict the pathological complete response of esophageal squamous cell carcinoma patients treated with neoadjuvant immunochemotherapy with or without short-term radiation as well as to assess the efficacy and safety of short-term radiotherapy in PROs-insensitive patients after one cycle of neoadjuvant immunochemotherapy.
- Being tested
- Paclitaxel-albumin, Cisplatin, Carboplatin, Tislelizumab, VMAT or IMRT
- Keywords
- Pathological complete response, Efficacy, Safety, Dysphagia
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-albuminDrug
260mg/m2, ivdrip, d1
CisplatinDrug
60mg/m2, ivdrip, d1
CarboplatinDrug
AUC=4-6, ivdrip, d1
TislelizumabDrug
200mg, ivdrip, d1
VMAT or IMRTRadiation
15Gy/5F (d43-d50, d57-d64), 5 times a week
EsophagectomyProcedure or surgery
Minimally-invasive or open McKeown and Ivor-Lewis esophagectomy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant immunochemotherapy +/- short-term radiotherapy | Experimental | Tislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy Receives: Drug: Paclitaxel-albumin; Drug: Cisplatin; Drug: Carboplatin; Drug: Tislelizumab; Radiation: VMAT or IMRT; Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response rate
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
Secondary outcomes (7)
Objective Response Rate (ORR)
iRECIST criteria defined complete response and partial response
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
R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resction rate
The R0 resection rate of esophagectomy
Measured: Three to five working days after surgery
Major pathological response
less than 10% residual viable tumor follow neoadjuvant therapy
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
Dysphagia relief score
DRS
Measured: score calculated by EORTC OES-18 dysphagia scale criteria at each cycle up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start30 Nov 2022 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (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 Esophageal Squamous Cell CarcinomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guibin Qiao, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596890
- Sponsor's protocol ID
- RICE-PICCRT
- Acronym
- PICCRT
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang S, Yu H, Li Z, Tang Y, Luo L, Wu J, Li X, Shi Q, Xie S, Qiao G. Electronic patient-reported outcome-based surveillance system to evaluate safety and efficacy of preoperative immunochemotherapy with or without short-term chemoradiation in patients with esophageal squamous cell carcinoma (ePRO-PICCRT): protocol for a prospective, single-arm, phase II study. J Thorac Dis. 2024 Jul 30;16(7):4719-4726. doi: 10.21037/jtd-24-274. Epub 2024 Jul 8.
PubMed 39144362
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcome-based Surveillance System Evaluating Safety and Efficacy of Preoperative Immunochemotherapy +/- Chemoradiation in Patients With Esophageal Squamous Cell Carcinoma - A Prospective, Explorative, Phase II Study
- ClinicalTrials.gov ID
- NCT05596890
- Acronym / sponsor ID
- PICCRT / RICE-PICCRT
- Keywords
- Pathological complete response, Efficacy, Safety, Dysphagia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 30 Nov 2022 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 27 Oct 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.
Preoperative Immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. However, there are still a significant proportion of patients who could not benefit from such treatment modality. Currently, no effective biomarkers were identified to stratify responders and non-responders. Early dynamic and persistent relief of dysphagia may act as a predictive biomarker to reflect the on-treatment anti-tumor activity. In this prospective study, we aimed to explore the feasibility of using patient-reported outcomes (PROs) to predict the pathological complete response of esophageal squamous cell carcinoma patients treated with neoadjuvant immunochemotherapy with or without short-term radiation as well as to assess the efficacy and safety of short-term radiotherapy in PROs-insensitive patients after one cycle of neoadjuvant immunochemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant immunochemotherapy +/- short-term radiotherapy | Experimental | Drug: Paclitaxel-albumin, Drug: Cisplatin, Drug: Carboplatin, Drug: Tislelizumab, Radiation: VMAT or IMRT, Procedure: EsophagectomyTislelizumab + cisplatin/carboplatin + albumin-bounded paclitaxel +/- radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed esophageal squamous cell carcinoma
- Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4aN1-2M0, cT3-T4aN0M0)
- Treatment-naive
- Expected life span > 6 months
- Aged 18 - 75 years old
Key exclusion criteria (13 listed)
- Previous history of thoracic surgery or radiation
- Cervical or multi-origin esophageal cancer
- Known or suspected experimental drug allergy
- Pregnant or lactating women
- Esophagomediastianl fistula
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 |
|---|---|---|
| Paclitaxel-albumin260mg/m2, ivdrip, d1 | Drug | Neoadjuvant immunochemotherapy +/- short-term radiotherapy |
| Cisplatin60mg/m2, ivdrip, d1 | Drug | Neoadjuvant immunochemotherapy +/- short-term radiotherapy |
| CarboplatinAUC=4-6, ivdrip, d1 | Drug | Neoadjuvant immunochemotherapy +/- short-term radiotherapy |
| Tislelizumab200mg, ivdrip, d1 | Drug | Neoadjuvant immunochemotherapy +/- short-term radiotherapy |
| VMAT or IMRT15Gy/5F (d43-d50, d57-d64), 5 times a week | Radiation | Neoadjuvant immunochemotherapy +/- short-term radiotherapy |
| EsophagectomyMinimally-invasive or open McKeown and Ivor-Lewis esophagectomy | Procedure or surgery | Neoadjuvant immunochemotherapy +/- short-term radiotherapy |
Primary outcome
Pathologic complete response rate
Time frame: Three to five working days after surgery
The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 weeks
Safety as measured by number of participants with Grade 3 and 4 adverse events
Time frame: Up to 12 weeks
R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resection rate R0 resction rate
Time frame: Three to five working days after surgery
Major pathological response
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
Dysphagia relief score
Time frame: score calculated by EORTC OES-18 dysphagia scale criteria at each cycle up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Derived from this study: PubMed 39144362Huang S, Yu H, Li Z, Tang Y, Luo L, Wu J, Li X, Shi Q, Xie S, Qiao G. Electronic patient-reported outcome-based surveillance system to evaluate safety and efficacy of preoperative immunochemotherapy with or without short-term chemoradiation in patients with esophageal squamous cell carcinoma (ePRO-PICCRT): protocol for a prospective, single-arm, phase II study. J Thorac Dis. 2024 Jul 30;16(7):4719-4726. doi: 10.21037/jtd-24-274. Epub 2024 Jul 8.
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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
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 Paclitaxel-albumin, Cisplatin and Carboplatin in people with Esophageal Squamous Cell Carcinoma and Patient-reported Outcomes, run by Guangdong Provincial People's 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 8 inclusion and 13 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 28 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guibin Qiao, MD (13602749153, guibinqiao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response rate (time frame: Three to five working days after surgery). 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 NCT05596890, 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 28 Nov 2022.