Esophageal Squamous Cell CarcinomaPhase 2NCT04568200
Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Resectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Durvalumab, Carboplatin and Paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a study to evaluate the efficacy and safety of preoperative treatment with durvalumab combined with neoajuvant therapy (carboplatin, paclitaxel with/without radiation) in locally advanced resectable oesophageal squamous carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Durvalumab, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2020to 1 Jan 2024
- 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 proven squamous cell carcinoma of the esophagus.
- Surgical resectable (T3 or T4b, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS),PET/CT, Esophageal MRI and enhanced CT scan of neck, thorax and abdomen.
- Tumor length longitudinal ≤ 10 cm; if larger than 10 cm, inclusion should be discussed with the principal investigator.
- 18≤Age≤75.
- Tumor does not involve gastro-esophageal junction.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Adequate hematological, renal and hepatic functions defined as:
- neutrophiles ≥ 1.5 x 109/L platelets ≥ 100 x 109/L alanine transaminase≤2 x upper normal limit hemoglobin ≥ 5.6 mmol total bilirubin ≤ 1.5 x upper normal limit creatinine clearance (Cockroft) ≥60 ml/min
- Written, voluntary informed consent.
Who cannot join
- Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.
- T1, T2 tumors or in situ carcinoma.
- metastatic oesophageal cancer.
- Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
- Previous chemotherapy, radiotherapy, and/or treatment with checkpoint inhibitors.
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery.
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- Pulmonary fibrosis and/or severely impaired lung function precluding major surgery.
- Pre-existing motor or sensory neurotoxicity greater than WHO grade 1.
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
- Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.
- Has an active infection requiring systemic therapy which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment.
- Has a diagnosis of acute or chronic hepatitis B, hepatitis C, known immunodeficiency or human immunodeficiency virus (HIV).
- Patients with prior allogeneic stem cell or solid organ transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Prospective, Randomized Controlled Study to Evaluate the Efficacy and Safety of Durvalumab Combined With Neoadjuvant Therapy in Patients With Local Advanced Esophageal Squamous Cell Carcinoma
This is a study to evaluate the efficacy and safety of preoperative treatment with durvalumab combined with neoajuvant therapy (carboplatin, paclitaxel with/without radiation) in locally advanced resectable oesophageal squamous carcinoma.
Read the detailed description
The primary objective of the study is to assess the tumor response (by irRECIST) and pathological response of preoperative treatment with durvalumab combined with neoadjuvant therapy (carboplatin, paclitaxel with/without radiation).
Secondary objectives are:
To assess completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment.
To assess toxicities of durvalumab in combination with chemoradiation. [Time Frame: up to 1 year] To assess completion of chemotherapy with/without radiation treatment. To assess withdrawal rate from surgery. To assess delay rate from surgery. To assess R0 resection rate. To assess post-operative complications. Progression Free Survival. [ Time Frame: up to 24 months ] Overall Survival. [ Time Frame: up to 24 months ]
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Durvalumab, Carboplatin, Paclitaxel, Radiotherapy 23 x 1.8 Gy
- 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.
DurvalumabDrug
Durvalumab 1500mg i.v. day 1-22-43-64
CarboplatinDrug
Also called Chemotherapy
Chemotherapy
PaclitaxelDrug
Also called Chemotherapy
Chemotherapy
Radiotherapy 23 x 1.8 GyRadiation
Also called Radiotherapy
Radiotherapy 23 x 1.8 Gy
| Study group | Role | What they receive |
|---|---|---|
| durvalumab and neoadjuvant therapy | Experimental | durvalumab 1500mg i.v. day 1-22-43-64 Carboplatin AUC = 4-5 i.v day 1-22-43-64 Paclitaxel 75 mg/m2 i.v day 1-22-43-64 with/without Radiotherapy 23 x 1.8 Gy Receives: Drug: Durvalumab; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiotherapy 23 x 1.8 Gy |
| normal saline and neoadjuvant therapy | Placebo comparator | normal saline 500ml i.v. day 1-22-43-64 Carboplatin AUC = 4-5 i.v day 1-22-43-64 Paclitaxel 75 mg/m2 i.v day 1-22-43-64 with/without Radiotherapy 23 x 1.8 Gy Receives: Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiotherapy 23 x 1.8 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response
assess the tumor response (by irRECIST) of preoperative treatment with durvalumab combined with neoadjuvant therapy
Measured: up to 12 months
pathological response
assess the pathological response (by CAP classification) of preoperative treatment with durvalumab combined with neoadjuvant therapy
Measured: up to 12 months
Secondary outcomes (9)
Percentage completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment
Percentage completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment
Measured: up to 3 months
Incidence and severity of toxicity
Incidence and severity of toxicity defined to CTCAE v4.03 and Radiation Oncology Group (RTOG) criteria
Measured: up to 12 months
Percentage completion of chemotherapy with/without radiation treatment
Percentage completion of chemotherapy with/without radiation treatment
Measured: up to 3 months
Percentage withdrawal rate from surgery due to durvalumab related complications
Percentage withdrawal rate from surgery due to durvalumab related complications
Measured: up to 3 months
Percentage delay of surgery due to durvalumab related complications
Percentage delay of surgery due to durvalumab related complications
Measured: up to 3 months
R0 resection rate
R0 resection rate
Measured: up to 3 months
Incidence and severity of post-operative complications to the Dindo classification
Incidence and severity of post-operative complications to the Dindo classification
Measured: up to 3 months
Progression free survival
Progression free survival
Measured: up to 24 months
Overall survival
Overall survival
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start19 Jun 2020
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia He, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568200
- Sponsor's protocol ID
- 69152630
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2020
- Last updated
- 22 Jan 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 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study to Evaluate the Efficacy and Safety of Durvalumab Combined With Neoadjuvant Therapy in Patients With Local Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04568200
- Acronym / sponsor ID
- 69152630
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 29 Sep 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 is a study to evaluate the efficacy and safety of preoperative treatment with durvalumab combined with neoajuvant therapy (carboplatin, paclitaxel with/without radiation) in locally advanced resectable oesophageal squamous carcinoma.
Detailed description
The primary objective of the study is to assess the tumor response (by irRECIST) and pathological response of preoperative treatment with durvalumab combined with neoadjuvant therapy (carboplatin, paclitaxel with/without radiation).
Secondary objectives are:
To assess completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment.
To assess toxicities of durvalumab in combination with chemoradiation. [Time Frame: up to 1 year] To assess completion of chemotherapy with/without radiation treatment. To assess withdrawal rate from surgery. To assess delay rate from surgery. To assess R0 resection rate. To assess post-operative complications. Progression Free Survival. [ Time Frame: up to 24 months ] Overall Survival. [ Time Frame: up to 24 months ]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| durvalumab and neoadjuvant therapy | Experimental | Drug: Durvalumab, Drug: Carboplatin, Drug: Paclitaxel, Radiation: Radiotherapy 23 x 1.8 Gydurvalumab 1500mg i.v. day 1-22-43-64 Carboplatin AUC = 4-5 i.v day 1-22-43-64 Paclitaxel 75 mg/m2 i.v day 1-22-43-64 with/without Radiotherapy 23 x 1.8 Gy |
| normal saline and neoadjuvant therapy | Placebo comparator | Drug: Carboplatin, Drug: Paclitaxel, Radiation: Radiotherapy 23 x 1.8 Gynormal saline 500ml i.v. day 1-22-43-64 Carboplatin AUC = 4-5 i.v day 1-22-43-64 Paclitaxel 75 mg/m2 i.v day 1-22-43-64 with/without Radiotherapy 23 x 1.8 Gy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven squamous cell carcinoma of the esophagus.
- Surgical resectable (T3 or T4b, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS),PET/CT, Esophageal MRI and enhanced CT scan of neck, thorax and abdomen.
- Tumor length longitudinal ≤ 10 cm; if larger than 10 cm, inclusion should be discussed with the principal investigator.
- 18≤Age≤75.
- Tumor does not involve gastro-esophageal junction.
Key exclusion criteria (15 listed)
- Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.
- T1, T2 tumors or in situ carcinoma.
- metastatic oesophageal cancer.
- Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
- Previous chemotherapy, radiotherapy, and/or treatment with checkpoint inhibitors.
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 |
|---|---|---|
| DurvalumabDurvalumab 1500mg i.v. day 1-22-43-64 | Drug | durvalumab and neoadjuvant therapy |
| CarboplatinAlso: ChemotherapyChemotherapy | Drug | durvalumab and neoadjuvant therapy, normal saline and neoadjuvant therapy |
| PaclitaxelAlso: ChemotherapyChemotherapy | Drug | durvalumab and neoadjuvant therapy, normal saline and neoadjuvant therapy |
| Radiotherapy 23 x 1.8 GyAlso: RadiotherapyRadiotherapy 23 x 1.8 Gy | Radiation | durvalumab and neoadjuvant therapy, normal saline and neoadjuvant therapy |
Primary outcome
tumor response
Time frame: up to 12 months
assess the tumor response (by irRECIST) of preoperative treatment with durvalumab combined with neoadjuvant therapy
pathological response
Time frame: up to 12 months
assess the pathological response (by CAP classification) of preoperative treatment with durvalumab combined with neoadjuvant therapy
9 secondary outcomes
Percentage completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment
Time frame: up to 3 months
Incidence and severity of toxicity
Time frame: up to 12 months
Percentage completion of chemotherapy with/without radiation treatment
Time frame: up to 3 months
Percentage withdrawal rate from surgery due to durvalumab related complications
Time frame: up to 3 months
Percentage delay of surgery due to durvalumab related complications
Time frame: up to 3 months
R0 resection rate
Time frame: up to 3 months
Incidence and severity of post-operative complications to the Dindo classification
Time frame: up to 3 months
Progression free survival
Time frame: up to 24 months
Overall survival
Time frame: up to 24 months
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 22 Jan 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. This study is not recruiting at the moment.
Jia He, MD study chair
Peking Union Medical College 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 Durvalumab, Carboplatin and Paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Peking Union Medical College 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 9 inclusion and 15 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 22 Jan 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. Some participants in this study may receive a placebo. 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?
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?
tumor response (time frame: up to 12 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?
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 22 Jan 2024.