Esophageal CancerPhase 2NCT05183958
A Multicenter, Randomized Controlled, Phase II Clinical Study of First-line Chemotherapy and Camrelizumab With or Without Radiotherapy in the Treatment of Oligometastatic Esophageal Cancer
A Phase 2 study testing Radiotherapy group, Camrelizumab and Chemotherapy in people with Esophageal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
A multi-center, open, randomized controlled, phase II clinical study to evaluate the efficiency and safety of chemotherapy and immunotherapy combined with locol radiotharepy in treatment of patients with oligometastatic esophageal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Radiotherapy group, Camrelizumab and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 1 Dec 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
- Age ≥18 years old and ≤75 years old, regardless of gender;
- Histologically or cytologically confirmed recurrent or metastatic esophageal squamous cell carcinoma;
- Non-regional lymph node metastasis, such as upper neck, retroperitoneal or axillary lymph node metastasis; or distant metastasis, but no more than 3 metastatic organs, and no more than 5 lesions;
- Patients who have not received other systems of anti-tumor treatment; the patients who have received neoadjuvant/adjuvant and radical concurrent radiochemotherapy, and the last treatment time or progress time exceeds 6 months;
- Patients who have not progressed after receiving 4 courses of chemotherapy combined with PD-1 immune checkpoint inhibitor treatment (according to the RECIST 1.1 evaluation standard);
- There are measurable lesions according to the RECIST 1.1 standard (cavity structures such as the esophagus cannot be used as measurable lesions), and the measurable lesions should not have received local treatment such as radiotherapy;
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- ECOG PS score is 0～1;
- For non-surgically sterilized female patients of childbearing age, the serum or urine HCG test must be negative within 72 hours before randomization;
- Volunteer to participate in clinical research: fully understand and know the research and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all trial procedures;
- Have not received immunotherapy or biological therapy before;
- Hemoglobin ≥90g/L, platelets ≥10×10 9 /L, absolute neutrophil count ≥1.5×10 9 /L;
- Serum creatinine ≤ 1.5 times UNL;
- Serum bilirubin≤1.5×UNL, AST (SGOT) and ALT (SGPT)≤2.5×UNL, alkaline phosphatase≤5×UNL;
- Coagulation function: INR≤1.5 × ULN; if the patient is receiving anticoagulation therapy, PT or APTT is within the acceptable range of treatment;
- There was no history of interstitial pneumonia or previous interstitial pneumonia.
Who cannot join
- In addition to the systemic treatment recommended by this program, patients have received other immune checkpoint inhibitor treatments such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies in the past, or any other antibodies or drugs with specific targets for T cell costimulation or checkpoint pathways;
- Patients have received radiotherapy in the past, and the tumor in the irradiation field has progressed;
- BMI<18.5kg/m 2 , or weight loss >10% within 2 months before screening ;
- With brain metastases;
- With metastasis of the meninges, pleura or pericardium;
- Esophageal perforation and active esophageal bleeding, with invasion of trachea and large blood vessels in the thoracic cavity;
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- Those who confirmed tumor progression during systemic treatment (RECIST 1.1 standard);
- Severe symptoms of dysphagia caused by tumor compression require immediate radiotherapy intervention to relieve the obstruction;
- Systemic treatment toxicity did not return to ≤ CTCAE level 1 (except for hair loss) or the level specified by the inclusion/exclusion criteria;
- Subjects have cardiovascular diseases or clinical symptoms that are not well controlled, including but not limited to: (1) Heart failure above NYHA II; (2) Unstable angina; (3) Myocardial infarction within 1 year; ( 4) Clinically significant supraventricular tachycardia or ventricular arrhythmia without clinical intervention, or poor control after clinical intervention;
- Patients with severe lung disease, interstitial pneumonia, or previous history of interstitial pneumonia:
- Autoimmune diseases (such as: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next step of screening: type I diabetes, skin diseases that do not require systemic treatment ( Such as vitiligo, psoriasis);
- Patients have active hepatitis B (HBV DNA≥2000IU/L or 104copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method);
- Suffered from an active infection requiring systemic treatment 14 days before the first administration;
- Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection 1 year before enrollment, or patients with active pulmonary tuberculosis infection more than 1 year ago but without formal treatment;
- Patients with other malignant lesions, except for curable skin cancer (non-melanoma), cervical carcinoma in situ or malignant disease cured ≥ 5 years;
- Patients who cannot understand the test requirements or may not comply with the test requirements;
- The investigator believes that some obvious diseases should be excluded from this study;
- The dose limit of radiotherapy cannot meet the limit requirement set by this study.
Trial locations and contacts
1 site in 1 country.
About this study
A multi-center, open, randomized controlled, phase II clinical study to evaluate the efficiency and safety of chemotherapy and immunotherapy combined with locol radiotharepy in treatment of patients with oligometastatic esophageal carcinoma.
Read the detailed description
This is a multi-center, open, randomized controlled, phase II clinical study to evaluate the efficiency and safety of chemotherapy and immunotherapy combined with locol radiotharepy in treatment of patients with oligometastatic esophageal carcinoma.For patients required that recurrent or metastatic esophageal cancer, no more than 3 metastatic organs and no more than 5 metastatic lesions. First, all patients receive chemotherapy (the regimen includes paclitaxel and platinum drugs; or cisplatin, pentafluorouracil (5-fluorouracil) ) and other standard first-line chemotherapeutics, combined with Camrelizumab for 4 cycles, and the patients who have not progressed were randomly divided into non-radiotherapy group (control group) and combined radiotherapy group (experimental group) at 1:1 ratio. The experimental group received radiotherapy of the lesion within 8 weeks after the end of chemotherapy and immunotherapy. At least one lesion (both primary and metastatic lesions) was required to be irradiated. Stereotactic body radiotherapy (SBRT, 8Gy/time, 3 -5 times, if other segmentation schemes are used, recommend BED10 >60Gy) or conventional fractional radiotherapy (parts that are not suitable for SBRT, the total dose is more than 30Gy); the primary lesion should be treated with conventional fractional radiotherapy with a dose of 4000cGy or more;The radiotherapy of the primary lesions and metastases focus is carried out at the same time or sequentially, and immunotherapy shall be started within 8 weeks after the end of all radiotherapy. The control group continued Camrelizumab after 3 weeks of the 4 cycles of chemotherapy combined with immunotherapy. The maintenance immunotherapy of the two groups was: Camrelizumab 200mg Q3W, until PD or toxicity is intolerable or up to 24 months. The endpoint are PFS, OS, ORR and toxicity of the two groups .
- Conditions
- Esophageal Cancer
- Being tested
- Radiotherapy group, Camrelizumab, Chemotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy groupRadiation
Stereotactic body radiotherapy (SBRT, 8Gy/time, 3 -5 times, if other segmentation schemes are used, recommend BED10 >60Gy) or conventional fractional radiotherapy (parts that are not suitable for SBRT, the total dose is more than 30Gy); the primary lesion should be treated with conventional fractional radiotherapy with a dose of 4000cGy or more;
CamrelizumabDrug
4 cycles for combined therapy. Camrelizumab maintenance.
ChemotherapyDrug
4 cycles for combined therapy.
| Study group | Role | What they receive |
|---|---|---|
| Combined radiotherapy group | Experimental | Chemotherapy :TP program (paclitaxel 175mg/m 2 d1, carboplatin AUC=5 d1 IV Q3W; or paclitaxel 175mg/m 2 d1, cisplatin 75mg/m 2 d1, or paclitaxel 175mg/m 2 d1, cis Platinum 25mg/m 2 d1-3 IV (Q3W, up to 4 cycles). Fluorouracil + cisplatin, cisplatin 80 mg/m 2 d1 IV and 5-Fu 800 mg/m 2 continuous IV d1-5 Q3W (up to 4 cycles).Or cisplatin 50mg/m 2 IV d1; LV 200mg/m 2 IV d1; 5-Fu 2000mg/m 2 24 hours continuous IV d1; or cisplatin 80mg/m 2 IV d1, capecitabine 1000mg/m 2 PO BID d1-14.
Camrelizumab :200mg every 3 weeks,maximum 6 cycles.
The experimental group received radiotherapy of the lesion within 8 weeks after the end of chemotherapy and immunotherapy. Immunotherapy shall be started within 8 weeks after the end of all radiotherapy.
The maintenance immunotherapy of the two groups was: Camrelizumab 200mg Q3W, until PD or toxicity is intolerable or up to 24 months. Receives: Radiation: Radiotherapy group; Drug: Camrelizumab; Drug: Chemotherapy |
| Non-radiotherapy group | Placebo comparator | Chemotherapy :TP program (paclitaxel 175mg/m 2 d1, carboplatin AUC=5 d1 IV Q3W; or paclitaxel 175mg/m 2 d1, cisplatin 75mg/m 2 d1, or paclitaxel 175mg/m 2 d1, cis Platinum 25mg/m 2 d1-3 IV (Q3W, up to 4 cycles). Fluorouracil + cisplatin, cisplatin 80 mg/m 2 d1 IV and 5-Fu 800 mg/m 2 continuous IV d1-5 Q3W (up to 4 cycles).Or cisplatin 50mg/m 2 IV d1; LV 200mg/m 2 IV d1; 5-Fu 2000mg/m 2 24 hours continuous IV d1; or cisplatin 80mg/m 2 IV d1, capecitabine 1000mg/m 2 PO BID d1-14.
Camrelizumab :200mg every 3 weeks,maximum 6 cycles.
The control group continued Camrelizumab after 3 weeks of the 4 cycles of chemotherapy combined with immunotherapy.
The maintenance immunotherapy of the two groups was: Camrelizumab 200mg Q3W, until PD or toxicity is intolerable or up to 24 months. Receives: Drug: Camrelizumab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression.
Measured: Up to 24 month
Secondary outcomes (3)
Objective Response Rate (ORR)
The percentage of patients with CR and PR assessed by investigators according to Recist v 1.Subjects evaluated as CR and PR need to be confirmed after 4 weeks (the next curative effect evaluation time specified in the protocol).
Measured: Up to 24 month
Overall survival (OS)
OS, defined as the time from randomization to death due to any cause.
Measured: Up to 24 month
Adverse Events (AEs)
Adverse Events Monitor and evaluate the safety of the treatment during the whole course of treatment and 30 days after the end of the last treatment. If severe toxicity occurs, monitor until 90 days after the end of treatment.According to CTCAE 5.0, the toxicity is classified and recorded.
Measured: Up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start31 Dec 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Wenzhou Medical Univercity, Jinhua Municipal Central Hospital, Lishui Municipal Central Hospital, The Affiliated People's Hospital of Ningbo University, Huizhou Municipal Central Hospital, People's Hospital of Quzhou, Sun Yat-Sen University Cancer Center
- Responsible party
- Principal investigator, ji yongling, Zhejiang Cancer Hospital
- Investigators
- yongling Ji, MD, Principal investigator, Zhejiang Cancer HospitalXianghui Du, MD, Principal investigator, Zhejiang Cancer HospitalMing Chen, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183958
- Sponsor's protocol ID
- IRB-2021-389
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled, Phase II Clinical Study of First-line Chemotherapy and Camrelizumab With or Without Radiotherapy in the Treatment of Oligometastatic Esophageal Cancer
- ClinicalTrials.gov ID
- NCT05183958
- Acronym / sponsor ID
- IRB-2021-389
- Conditions
- Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, The First Affiliated Hospital of Wenzhou Medical Univercity, Jinhua Municipal Central Hospital, Lishui Municipal Central Hospital, The Affiliated People's Hospital of Ningbo University, Huizhou Municipal Central Hospital, People's Hospital of Quzhou, Sun Yat-Sen University Cancer Center
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Jan 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.
A multi-center, open, randomized controlled, phase II clinical study to evaluate the efficiency and safety of chemotherapy and immunotherapy combined with locol radiotharepy in treatment of patients with oligometastatic esophageal carcinoma.
Detailed description
This is a multi-center, open, randomized controlled, phase II clinical study to evaluate the efficiency and safety of chemotherapy and immunotherapy combined with locol radiotharepy in treatment of patients with oligometastatic esophageal carcinoma.For patients required that recurrent or metastatic esophageal cancer, no more than 3 metastatic organs and no more than 5 metastatic lesions. First, all patients receive chemotherapy (the regimen includes paclitaxel and platinum drugs; or cisplatin, pentafluorouracil (5-fluorouracil) ) and other standard first-line chemotherapeutics, combined with Camrelizumab for 4 cycles, and the patients who have not progressed were randomly divided into non-radiotherapy group (control group) and combined radiotherapy group (experimental group) at 1:1 ratio. The experimental group received radiotherapy of the lesion within 8 weeks after the end of chemotherapy and immunotherapy. At least one lesion (both primary and metastatic lesions) was required to be irradiated. Stereotactic body radiotherapy (SBRT, 8Gy/time, 3 -5 times, if other segmentation schemes are used, recommend BED10 >60Gy) or conventional fractional radiotherapy (parts that are not suitable for SBRT, the total dose is more than 30Gy); the primary lesion should be treated with conventional fractional radiotherapy with a dose of 4000cGy or more;The radiotherapy of the primary lesions and metastases focus is carried out at the same time or sequentially, and immunotherapy shall be started within 8 weeks after the end of all radiotherapy. The control group continued Camrelizumab after 3 weeks of the 4 cycles of chemotherapy combined with immunotherapy. The maintenance immunotherapy of the two groups was: Camrelizumab 200mg Q3W, until PD or toxicity is intolerable or up to 24 months. The endpoint are PFS, OS, ORR and toxicity of the two groups .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined radiotherapy group | Experimental | Radiation: Radiotherapy group, Drug: Camrelizumab, Drug: ChemotherapyChemotherapy :TP program (paclitaxel 175mg/m 2 d1, carboplatin AUC=5 d1 IV Q3W; or paclitaxel 175mg/m 2 d1, cisplatin 75mg/m 2 d1, or paclitaxel 175mg/m 2 d1, cis Platinum 25mg/m 2 d1-3 IV (Q3W, up to 4 cycles). Fluorouracil + cisplatin, cisplatin 80 mg/m 2 d1 IV and 5-Fu 800 mg/m 2 continuous IV d1-5 Q3W (up to 4 cycles).Or cisplatin 50mg/m 2 IV d1; LV 200mg/m 2 IV d1; 5-Fu 2000mg/m 2 24 hours continuous IV d1; or cisplatin 80mg/m 2 IV d1, capecitabine 1000mg/m 2 PO BID d1-14. Camrelizumab :200mg every 3 weeks,maximum 6 cycles. The experimental group received radiotherapy of the lesion within 8 weeks after the end of chemotherapy and immunotherapy. Immunotherapy shall be started within 8 weeks after the end of all radiotherapy. The maintenance immunotherapy of the two groups was: Camrelizumab 200mg Q3W, until PD or toxicity is intolerable or up to 24 months. |
| Non-radiotherapy group | Placebo comparator | Drug: Camrelizumab, Drug: ChemotherapyChemotherapy :TP program (paclitaxel 175mg/m 2 d1, carboplatin AUC=5 d1 IV Q3W; or paclitaxel 175mg/m 2 d1, cisplatin 75mg/m 2 d1, or paclitaxel 175mg/m 2 d1, cis Platinum 25mg/m 2 d1-3 IV (Q3W, up to 4 cycles). Fluorouracil + cisplatin, cisplatin 80 mg/m 2 d1 IV and 5-Fu 800 mg/m 2 continuous IV d1-5 Q3W (up to 4 cycles).Or cisplatin 50mg/m 2 IV d1; LV 200mg/m 2 IV d1; 5-Fu 2000mg/m 2 24 hours continuous IV d1; or cisplatin 80mg/m 2 IV d1, capecitabine 1000mg/m 2 PO BID d1-14. Camrelizumab :200mg every 3 weeks,maximum 6 cycles. The control group continued Camrelizumab after 3 weeks of the 4 cycles of chemotherapy combined with immunotherapy. The maintenance immunotherapy of the two groups was: Camrelizumab 200mg Q3W, until PD or toxicity is intolerable or up to 24 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 years old and ≤75 years old, regardless of gender;
- Histologically or cytologically confirmed recurrent or metastatic esophageal squamous cell carcinoma;
- Non-regional lymph node metastasis, such as upper neck, retroperitoneal or axillary lymph node metastasis; or distant metastasis, but no more than 3 metastatic organs, and no more than 5 lesions;
- Patients who have not received other systems of anti-tumor treatment; the patients who have received neoadjuvant/adjuvant and radical concurrent radiochemotherapy, and the last treatment time or progress time exceeds 6 months;
- Patients who have not progressed after receiving 4 courses of chemotherapy combined with PD-1 immune checkpoint inhibitor treatment (according to the RECIST 1.1 evaluation standard);
Key exclusion criteria (19 listed)
- In addition to the systemic treatment recommended by this program, patients have received other immune checkpoint inhibitor treatments such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies in the past, or any other antibodies or drugs with specific targets for T cell costimulation or checkpoint pathways;
- Patients have received radiotherapy in the past, and the tumor in the irradiation field has progressed;
- BMI<18.5kg/m 2 , or weight loss >10% within 2 months before screening ;
- With brain metastases;
- With metastasis of the meninges, pleura or pericardium;
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 |
|---|---|---|
| Radiotherapy groupStereotactic body radiotherapy (SBRT, 8Gy/time, 3 -5 times, if other segmentation schemes are used, recommend BED10 >60Gy) or conventional fractional radiotherapy (parts that are not suitable for SBRT, the total dose is more than 30Gy); the primary lesion should be treated with conventional fractional radiotherapy with a dose of 4000cGy or more; | Radiation | Combined radiotherapy group |
| Camrelizumab4 cycles for combined therapy. Camrelizumab maintenance. | Drug | Combined radiotherapy group, Non-radiotherapy group |
| Chemotherapy4 cycles for combined therapy. | Drug | Combined radiotherapy group, Non-radiotherapy group |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 24 month
PFS, defined as the time from randomization to the first occurrence of disease progression.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 month
Overall survival (OS)
Time frame: Up to 24 month
Adverse Events (AEs)
Time frame: Up to 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
yongling Ji, MD principal investigator
Zhejiang Cancer Hospital
Xianghui Du, MD principal investigator
Zhejiang Cancer Hospital
Ming Chen, MD principal investigator
Sun Yat-Sen University Cancer Center
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 Radiotherapy group, Camrelizumab and Chemotherapy in people with Esophageal Cancer, run by Zhejiang Cancer 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 15 inclusion and 19 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 11 Jan 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yongling Ji, MD (13958085251, wangjin@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to 24 month). 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 11 Jan 2022.