Neoadjuvant TherapyPhase 2/3NCT06354530
A Study of Neoadjuvant Therapy for the Treatment of Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2/3 study testing anlotinib and Thoracic radiotherapy in people with Neoadjuvant Therapy and Esophageal Squamous Cell Carcinoma, run by Army Medical Center of PLA at 1 site in China.
Trial summary
The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neoadjuvant Therapy, Esophageal Squamous Cell Carcinoma
- What is being tested?
- anlotinib and Thoracic radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2024to 31 Dec 2026
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgically resectable cT1-4aN+M0 or cT3-4aN0M0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology
- Patients who can take anlotinib capsules orally
- No previous systematic antitumor treatment
- ECOG PS 0-1
- The function of important organs meets the following requirements: absolute neutrophil count≥1.5×10^9 / L; platelet≥80×10^9 / L; hemoglobin≥80×10^9 / L; total bilirubin≤1.5×upper limit of normal; within normal serum creatinine; ALT and glutamatergic aminase≤2.5× upper limit of normal
- No incurable serious complications or other major diseases
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- The thoracic surgeon judges that the operation can be tolerated
- Female subjects with fertility, and male subjects with childbearing partners, required a medically approved contraceptive during study treatment and at least 6 months after the last chemotherapy
- The subjects volunteered to join the study, signed informed consent, had good compliance and cooperated with follow-up
Who cannot join
- BMI\<18.5kg/m2 or 10% weight loss in 2 months before screening (while considering the effect of large chest ascites on body weight)
- Patients with tracheal / bronchial / macrovascular invasion, deep ulcer esophagus, digestive tract perforation and / or fistula, major bleeding, and poor lung function or previous chronic lung disease within 6 months prior to initial medication
- Patients with significant feeding obstruction unable to take oral anlotinib
- Known history of allergy to any component of biological or PD-1 mab formulation, albumin-bound paclitaxel, carboplatin and other platinum drugs manufactured by Chinese hamster ovary cells (CHO)
- Have received any of the following treatments: any investigational drug; enrolled in another clinical study except for an observational (non-interventional) clinical study; received anti-tumor or live vaccine
- A history of active autoimmune diseases and autoimmune diseases
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- A history of immunodeficiency, including a positive HIV test, or other acquired, congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation
- The subject had cardiovascular clinical symptoms or disease that were not well controlled
- Patients with active hepatitis B or hepatitis C and active pulmonary tuberculosis
- Severe infection (CTCAE\> 2) occurred within 4 weeks prior to initial use of study drug, such as severe pneumonia, bacteremia, infection requiring hospitalization; baseline chest imaging indicated active lung inflammation, symptoms and signs of infection within 2 weeks prior to initial use of study drug or the need for oral or intravenous antibiotics, except for prophylactic antibiotics
- Major surgery (except diagnostic surgery) within 28 days prior to treatment, or is expected to undergo major surgery during the study
- Any other malignancy had been diagnosed within 5 years prior to the first use of study drug, except for nausea tumors with low risk and mortality (5-year survival\> 90%), such as adequately treated basal or squamous cell skin carcinoma or carcinoma of the cervix
- Female patients during pregnancy or lactation and who were refused or unable to use contraception
- At the discretion of the investigator, the subject had other factors that could contribute to his forced termination
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Army Medical Center of PLA
Chongqing, None Selected
Mengxia Li, +86-18580408265, mengxia.li@outlook.com
Xiao Yang, +86-19923257675, yangxiao625@outlook.com
About this study
Official title: Neoadjuvant Immunotherapy Plus Chemotherapy and Anlotinib Versus Immunotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced ESCC
The goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.
Read the detailed description
The goal of this single-center, open-label, non-inferior, randomized controlled, interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.
- Being tested
- anlotinib, Thoracic 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.
anlotinibDrug
Drug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period
Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles
Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles
Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles
Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles
Drug: anlotinib 8 mg/day orally (from days 1 to 14 in a 21-day cycle) for 2 cycles
Thoracic radiotherapyRadiation
Also called radiotherapy
Drug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period
Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles
Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles
Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles
Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles
Thoracic radiotherapy RT once daily (from cycle 1 [C1D1], 41.4Gy/23Fx, 1.8Gy daily, for 4.6 weeks, 5 days/week)
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant immunotherapy plus chemotherapy and anlotinib | Experimental | neoadjuvant immunotherapy plus chemotherapy and anlotinib Receives: Radiation: Thoracic radiotherapy |
| neoadjuvant immunotherapy combined with concurrent chemoradiotherapy | Experimental | neoadjuvant immunotherapy combined with concurrent chemoradiotherapy Receives: Drug: anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR), Major pathological response (MPR)
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes
Measured: Up to approximately 15 weeks after randomization
Major pathological response (MPR)
Major pathological response (MPR)
Measured: Up to approximately 15 weeks after randomization
Secondary outcomes (4)
Objective response rate (ORR)
Objective response rate (ORR)
Measured: Up to approximately 15 weeks after randomization
3-year disease free survival
3-year disease free survival
Measured: From date of randomization to approximately 3 years after date of resection
R0 excision rate
R0 excision rate
Measured: Up to approximately 15 weeks after randomization
3-year overall survival
3-year overall survival
Measured: From date of randomization to approximately 3 years after date of resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start8 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TherapyStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Army Medical Center of PLA
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mengxia Li, Army Medical Center of PLA
- Investigators
- Jingjing Wang, Principal investigator, Army Medical Center of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354530
- Sponsor's protocol ID
- 2023 (315)
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 9 Apr 2024
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Immunotherapy Plus Chemotherapy and Anlotinib Versus Immunotherapy Combined With Concurrent Chemoradiotherapy in the Treatment of Locally Advanced ESCC
- ClinicalTrials.gov ID
- NCT06354530
- Acronym / sponsor ID
- 2023 (315)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Army Medical Center of PLAOther government
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Apr 2024 (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 goal of this interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for esophageal squamous cell carcinoma.
Detailed description
The goal of this single-center, open-label, non-inferior, randomized controlled, interventional study is to compare the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma. The main question it aims to answer is: To evaluate the safety and efficacy of neoadjuvant immunotherapy plus chemotherapy and anlotinib versus immunotherapy combined with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma and to explore the optimal preoperative neoadjuvant treatment regimen for 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 |
|---|---|---|
| neoadjuvant immunotherapy plus chemotherapy and anlotinib | Experimental | Radiation: Thoracic radiotherapyneoadjuvant immunotherapy plus chemotherapy and anlotinib |
| neoadjuvant immunotherapy combined with concurrent chemoradiotherapy | Experimental | Drug: anlotinibneoadjuvant immunotherapy combined with concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Surgically resectable cT1-4aN+M0 or cT3-4aN0M0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology
- Patients who can take anlotinib capsules orally
- No previous systematic antitumor treatment
- ECOG PS 0-1
- The function of important organs meets the following requirements: absolute neutrophil count≥1.5×10^9 / L; platelet≥80×10^9 / L; hemoglobin≥80×10^9 / L; total bilirubin≤1.5×upper limit of normal; within normal serum creatinine; ALT and glutamatergic aminase≤2.5× upper limit of normal
Key exclusion criteria (14 listed)
- BMI\<18.5kg/m2 or 10% weight loss in 2 months before screening (while considering the effect of large chest ascites on body weight)
- Patients with tracheal / bronchial / macrovascular invasion, deep ulcer esophagus, digestive tract perforation and / or fistula, major bleeding, and poor lung function or previous chronic lung disease within 6 months prior to initial medication
- Patients with significant feeding obstruction unable to take oral anlotinib
- Known history of allergy to any component of biological or PD-1 mab formulation, albumin-bound paclitaxel, carboplatin and other platinum drugs manufactured by Chinese hamster ovary cells (CHO)
- Have received any of the following treatments: any investigational drug; enrolled in another clinical study except for an observational (non-interventional) clinical study; received anti-tumor or live vaccine
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 |
|---|---|---|
| anlotinibDrug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Drug: anlotinib 8 mg/day orally (from days 1 to 14 in a 21-day cycle) for 2 cycles | Drug | neoadjuvant immunotherapy combined with concurrent chemoradiotherapy |
| Thoracic radiotherapyAlso: radiotherapyDrug: Camrelizumab 200mg on Day 1 of each 3-week cycle for 2 cycles during the neoadjuvant period Drug: Carboplatin Area under the curve of 5 on Day 1 of each 3-week cycle for 2 cycles Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 2 cycles Drug: Paclitaxel 135-175 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Drug: Nab-Paclitaxel 220-260 mg/m2 on Day 1 of each 3-week cycle for 2 cycles Thoracic radiotherapy RT once daily (from cycle 1 [C1D1], 41.4Gy/23Fx, 1.8Gy daily, for 4.6 weeks, 5 days/week) | Radiation | neoadjuvant immunotherapy plus chemotherapy and anlotinib |
Primary outcome
Pathological complete response (pCR), Major pathological response (MPR)
Time frame: Up to approximately 15 weeks after randomization
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes
Major pathological response (MPR)
Time frame: Up to approximately 15 weeks after randomization
Major pathological response (MPR)
4 secondary outcomes
Objective response rate (ORR)
Time frame: Up to approximately 15 weeks after randomization
3-year disease free survival
Time frame: From date of randomization to approximately 3 years after date of resection
R0 excision rate
Time frame: Up to approximately 15 weeks after randomization
3-year overall survival
Time frame: From date of randomization to approximately 3 years after date of resection
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 9 Apr 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.
Jingjing Wang principal investigator
Army Medical Center of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing anlotinib and Thoracic radiotherapy in people with Neoadjuvant Therapy and Esophageal Squamous Cell Carcinoma, run by Army Medical Center of PLA 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 9 inclusion and 14 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 9 Apr 2024. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mengxia Li (86-18580408265, mengxia.li@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR), Major pathological response (MPR) (time frame: Up to approximately 15 weeks after randomization). 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?
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 9 Apr 2024.