ChemotherapyPhase 2NCT05821452
Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma
A Phase 2 study testing Camrelizumab, Paclitaxel and Cisplatin in people with Chemotherapy and Radiation Therapy, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
The investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy of potentially resectable advanced esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy, Radiation Therapy
- What is being tested?
- Camrelizumab, 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
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2023to 30 May 2026
- 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
- histologically-confirmed squamous cell carcinoma
- primary lesions located in the thoracic esophagus
- clinical stage cT4 or at least one group of lymph nodes invade the surrounding organs and unresectable lymph nodes
- having not received neoadjuvant therapy
- 18-75 years
- ECOG performance status of 0 or 1
Show all 10Show fewer
- no prior chemotherapy, radiotherapy, or immunotherapy for any cancers
- adequate organ function
- expectation of R0 resection
- provision of written informed consent.
Who cannot join
- corticosteroid treatment (equivalent to prednisone >10 mg/day) within 14 days before the first day of the drug administration
- acquired immunodeficiency syndrome or active hepatitis B (DNA ≥ 104 copies/ml) or C (RNA ≥ 103 copies/ml) viral infections
- history of pneumonitis or interstitial lung disease with clinical evidence, such as interstitial pneumonia and pulmonary fibrosis features on baseline CT scans
- known or concurrent bleeding disorders or other uncontrolled diseases contraindicating surgical treatment
- physical examination or clinical trial findings that can interfere with the results or put the patient at increased risk for treatment complications
- comorbidities, including chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, and unstable mental disorders requiring therapy
Show all 9Show fewer
- allergy to drugs used in the study
- participation in other clinical trials within 30 days before enrollment
- ineligibility for participation based on the decision of investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction Therapy for Locally Advanced Tumor With Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma
The investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy of potentially resectable advanced esophageal squamous cell carcinoma. This study will provide more evidence for conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.
Read the detailed description
Esophageal cancer (EC) has a higher morbidity and mortality rate than most human malignancies. The standard treatment for unresectable locally advanced esophageal squamous cell carcinoma (ESCC) is concurrent chemoradiotherapy, but survival remains limited. Carrilizumab combined with chemotherapy has been shown to have an excellent pathological remission rate in the treatment of advanced esophageal cancer and locally advanced esophageal cancer. Here, the investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy in potentially resectable advanced esophageal squamous cell carcinoma. All participants meeting the inclusion criteria will be registered after signing the informed consent form. Patients with thoracic esophageal cancer with clinical staging of T4a and T4b or at least one group of lymph nodes likely to invade surrounding organs or with concomitant enlarged lymph nodes unresectable will be included in the study. According to the study plan, patients who completed two cycles of chemotherapy combined with Camrelizumab induction or concurrent chemoradiotherapy were randomly assigned to receive radical surgery after being assessed as operable. The primary endpoint was R0 removal rate in patients undergoing surgery after treatment. Secondary endpoints were major pathological response (MPR) rate, overall survival (OS), progression-free survival (PFS), and adverse events. This study will provide more evidence for the conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.
- Conditions
- Chemotherapy, Radiation Therapy
- Being tested
- Camrelizumab, Paclitaxel, Cisplatin, Radiotherapy
- Keywords
- Immumotherapy plus Chemotherapy, conversion therapy, advanced esophageal squamous cell carcinoma, chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Also called pdl1 Inhibitors
200mgQ3w
PaclitaxelDrug
Also called Paclitaxel For Injection (Albumin Bound)
175mg/m2，D1，Q3w
CisplatinDrug
75mg/m2，D1，Q3w
RadiotherapyRadiation
Also called Radiation therapy
41.4Gy, 1.8Gy each time, 5 times a week
| Study group | Role | What they receive |
|---|---|---|
| Immumotherapy plus Chemotherapy | Experimental | Paclitaxel: 175mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of 3 cycles.
Cisplatin: 75mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of 3 cycles.
Camrelizumab: 200mg was administered intravenously on the first day of each cycle, every 3 weeks as a cycle (Q3W), for a total of 3 cycles. Receives: Drug: Camrelizumab; Drug: Paclitaxel; Drug: Cisplatin |
| chemoradiotherapy | Experimental | Paclitaxel: 175mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of two cycles
Cisplatin: 75mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of two cycles
Radiotherapy: Irradiation mode and dose: three-dimensional conformal or intensity modulated radiotherapy technology was adopted, 41.4Gy, 1.8Gy each time, 5 times a week. Receives: Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 removal rate
R0 removal rate in patients undergoing surgery after treatment
Measured: up to 3 months
MPR rate
major pathological response rate
Measured: up to 4 months
Secondary outcomes (2)
OS
overall survival
Measured: 12 months
PFS
progression-free survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start25 May 2023 (estimated)
- Primary completion25 May 2024 (estimated)
- Study completion30 May 2026 (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 ChemotherapyStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun Chen, Prof, Study chair, Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821452
- Sponsor's protocol ID
- I-ICE Union
- Status last verified
- Apr 2023
- First submitted
- 14 Feb 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical trial registration, unbiased reporting of results and sharing of raw data
Publications
Chen M, Huang Y, Zhang S, Zheng Y, Zeng T, Chen C, Zheng B. Camrelizumab in combination with chemotherapy versus concurrent chemoradiotherapy for the conversion of locally advanced unresectable oesophageal squamous carcinoma: protocol for a two-arm, open-label phase II trial. BMJ Open. 2024 Feb 28;14(2):e075421. doi: 10.1136/bmjopen-2023-075421.
PubMed 38418234
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Therapy for Locally Advanced Tumor With Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT05821452
- Acronym / sponsor ID
- I-ICE Union
- Conditions
- Chemotherapy, Radiation Therapy
- Keywords
- Immumotherapy plus Chemotherapy, conversion therapy, advanced esophageal squamous cell carcinoma, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 25 May 2023 (estimated)
- Primary completion
- 25 May 2024 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 20 Apr 2023 (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 investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy of potentially resectable advanced esophageal squamous cell carcinoma. This study will provide more evidence for conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.
Detailed description
Esophageal cancer (EC) has a higher morbidity and mortality rate than most human malignancies. The standard treatment for unresectable locally advanced esophageal squamous cell carcinoma (ESCC) is concurrent chemoradiotherapy, but survival remains limited. Carrilizumab combined with chemotherapy has been shown to have an excellent pathological remission rate in the treatment of advanced esophageal cancer and locally advanced esophageal cancer. Here, the investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy in potentially resectable advanced esophageal squamous cell carcinoma. All participants meeting the inclusion criteria will be registered after signing the informed consent form. Patients with thoracic esophageal cancer with clinical staging of T4a and T4b or at least one group of lymph nodes likely to invade surrounding organs or with concomitant enlarged lymph nodes unresectable will be included in the study. According to the study plan, patients who completed two cycles of chemotherapy combined with Camrelizumab induction or concurrent chemoradiotherapy were randomly assigned to receive radical surgery after being assessed as operable. The primary endpoint was R0 removal rate in patients undergoing surgery after treatment. Secondary endpoints were major pathological response (MPR) rate, overall survival (OS), progression-free survival (PFS), and adverse events. This study will provide more evidence for the conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immumotherapy plus Chemotherapy | Experimental | Drug: Camrelizumab, Drug: Paclitaxel, Drug: CisplatinPaclitaxel: 175mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of 3 cycles. Cisplatin: 75mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of 3 cycles. Camrelizumab: 200mg was administered intravenously on the first day of each cycle, every 3 weeks as a cycle (Q3W), for a total of 3 cycles. |
| chemoradiotherapy | Experimental | Drug: Paclitaxel, Drug: Cisplatin, Radiation: RadiotherapyPaclitaxel: 175mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of two cycles Cisplatin: 75mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of two cycles Radiotherapy: Irradiation mode and dose: three-dimensional conformal or intensity modulated radiotherapy technology was adopted, 41.4Gy, 1.8Gy each time, 5 times a week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically-confirmed squamous cell carcinoma
- primary lesions located in the thoracic esophagus
- clinical stage cT4 or at least one group of lymph nodes invade the surrounding organs and unresectable lymph nodes
- having not received neoadjuvant therapy
- 18-75 years
Key exclusion criteria (9 listed)
- corticosteroid treatment (equivalent to prednisone >10 mg/day) within 14 days before the first day of the drug administration
- acquired immunodeficiency syndrome or active hepatitis B (DNA ≥ 104 copies/ml) or C (RNA ≥ 103 copies/ml) viral infections
- history of pneumonitis or interstitial lung disease with clinical evidence, such as interstitial pneumonia and pulmonary fibrosis features on baseline CT scans
- known or concurrent bleeding disorders or other uncontrolled diseases contraindicating surgical treatment
- physical examination or clinical trial findings that can interfere with the results or put the patient at increased risk for treatment complications
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 |
|---|---|---|
| CamrelizumabAlso: pdl1 Inhibitors200mgQ3w | Drug | Immumotherapy plus Chemotherapy |
| PaclitaxelAlso: Paclitaxel For Injection (Albumin Bound)175mg/m2，D1，Q3w | Drug | Immumotherapy plus Chemotherapy, chemoradiotherapy |
| Cisplatin75mg/m2，D1，Q3w | Drug | Immumotherapy plus Chemotherapy, chemoradiotherapy |
| RadiotherapyAlso: Radiation therapy41.4Gy, 1.8Gy each time, 5 times a week | Radiation | chemoradiotherapy |
Primary outcome
R0 removal rate
Time frame: up to 3 months
R0 removal rate in patients undergoing surgery after treatment
MPR rate
Time frame: up to 4 months
major pathological response rate
2 secondary outcomes
OS
Time frame: 12 months
PFS
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Derived from this study: PubMed 38418234Chen M, Huang Y, Zhang S, Zheng Y, Zeng T, Chen C, Zheng B. Camrelizumab in combination with chemotherapy versus concurrent chemoradiotherapy for the conversion of locally advanced unresectable oesophageal squamous carcinoma: protocol for a two-arm, open-label phase II trial. BMJ Open. 2024 Feb 28;14(2):e075421. doi: 10.1136/bmjopen-2023-075421.
- Individual participant dataSharing planned: No. Clinical trial registration, unbiased reporting of results and sharing of raw data
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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.
Chun Chen, Prof study chair
Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu
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 Camrelizumab, Paclitaxel and Cisplatin in people with Chemotherapy and Radiation Therapy, run by Fujian Medical University Union 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 10 inclusion and 9 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 20 Apr 2023. 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 Chun Chen, Prof (13365910325, chenchun0209@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 removal rate (time frame: up to 3 months). The study lists 2 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 NCT05821452, 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 20 Apr 2023.