Adenocarcinoma of Esophagogastric JunctionPhase 2NICLANCT05505461
Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Esophagogastric Junction Adenocarcinoma
A Phase 2 study testing neoadjuvant Radiation plus SOX and PD-1 antibody in people with Adenocarcinoma of Esophagogastric Junction, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study was to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- neoadjuvant Radiation plus SOX and PD-1 antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- Jan 2023to Dec 2027
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of esophagogastric junction, and Her-2 negative.
- Clinically diagnosed stage T3+orN+M0, according to CT/MRI scan.
- No prior anti-tumor treatment, including surgery, chemotherapy, radiotherapy, and targeted therapy.
- Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1.
- At least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is required.
- Expected survival ≥6 months.
Show all 12Show fewer
- Adequate organ function, Hemoglobin ≥90g/L; White blood cells ≥3.0×109/L; neutrophil count ≥1.5×109/L; Platelets ≥100×109/L; Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the ULN; Urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification shows that protein must be ≤ 1 g.
- Normal coagulation function, no active bleeding and thrombotic diseases: International Standardized Ratio INR≤1.5×ULN; Partial thromboplastin time APTT≤1.5×ULN; Prothrombin time PT≤1.5ULN;
- Previous use of anti-tumor Chinese medicines, proprietary Chinese medicines, and immunomodulators (such as thymosin, interleukin, etc.) must be ≥ 2 weeks from the start of the study medication;
- Female patients should not be pregnant or breast feeding. Male should contraception.
- Able and willing to give informed consent to participate.
- Those who are expected to have good compliance.
Who cannot join
- Existence of other active malignant tumors within 5 years or at the same time.
- Already received chemotherapy, radiation therapy, targeted or immunotherapy.
- Have any active autoimmune disease or history of autoimmune disease.
- Patients with congenital or acquired immunodeficiency.
- Use of immunosuppressive drugs within 14 days before the study start.
- Administer live attenuated vaccines within 4 weeks before the study start.
Show all 13Show fewer
- Suffering from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) poorly controlled arrhythmia.
- Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, etc., and severely impaired lung function.
- Suffering from active pulmonary tuberculosis.
- Complicated severe infection within 4 weeks before the the study start, or unexplained fever >38.5°C during the screening period/before the study start.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- 13. Allergic to any drug in this study. 14. Combined with other severe, acute and chronic diseases that may increase the risk of participating.
- 15.Participators who had been recruited by other clinical trial within three months.
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
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Liyu Zhu, +8610-66583821, wcwkzlward@163.com
About this study
Official title: Efficacy and Safety of PD-1 Combined With Long-term Concurrent Neoadjuvant Chemoradiotherapy and Chemotherapy in the Treatment of Resectable Locally Advanced Esophagogastric Junction Adenocarcinoma： A Phase II Study
The purpose of this study was to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.
Read the detailed description
The incidence of adenocarcinoma of the esophagogastric junction (AEG) is increasing in Asian countries and Western Contries. Surgical resection is the most important treatment for AEG. However, the recurrence rate is high when surgery is performed alone. The results of CLASSIC, MAGIC, FLOT4, JCOG0501, PRODIGY, RESOLVE, CROSS trial showed that perioperative chemotherapy and pre- or postoperative chemoradiotherapy significantly increase the overall survival rate and disease free survival rate compared to surgery alone. Radiotherapy and immunotherapy can increase sensitivity to each other, and several clinical studies have also showed that PD-1 antibody may significantly prolongs the life.Thus the investigators plan to conduct this clinical trial to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.
Subjects will receive long-term radiotherapy (5w) concurrent with PD-1 antibody for 2 cycles, then receive two cycles of SOX regimen combined PD-1 after a week's rest. Surgery will be performed 2 weeks after the last cycle of neoadjuvant treatment. Adjuvant treatment will be started 3 to 8 weeks after surgery, and SOX regimen will be given for 4 cycles.
- Being tested
- neoadjuvant Radiation plus SOX and PD-1 antibody
- Keywords
- PD-1, neoadjuvant therapy, radiotherapy
- Medical subject headings
- Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant Radiation plus SOX and PD-1 antibodyDrug
Also called Neoadjuvant Chemoradiotherapy plus Immunotherapy
Patients will be given the perioperative treatment as below once recruited:
First, neoradiation (5w) will be given: intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas. PD-1 antibody will be started concurrent the radiation for 2 cycles.
The neochemotherapy (SOX) and PD-1 antibody will be given for 2 cycles after 1 week since radiation completed ; Patients will rest 2 weeks after the last cycle of neochemotherapy, and evaluation will be performed during this time. And D2 surgery will be performed if resectable.
SOX and PD-1 antibody will be given q3w. Adjuvant chemotherapy: We advise starting 4 cycles of SOX regimen in 3-8w after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therpy | Experimental | Neoadjuvant chemoradiation plus SOX and PD-1 antibody Receives: Drug: neoadjuvant Radiation plus SOX and PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Responce (pCR) Rate
Proportion of patients with AEG who received neoadjuvant theray with radiation plus PD-1 antibody and SOX regimen and postoperative pathological examination shows pathological complete responce
Measured: Up to 6 months
Secondary outcomes (4)
R0 Resection Rate
Proportion of patients with AEG who received surgery with pathological pathological examination proved microscopically margin-negative resection
Measured: Up to 6 months
Progression Free Survival (PFS)
Disease Free Survival was defined as the time from the date of surgery to the date of the local recurrence, and/or distant disease, or tumor-related death.
Measured: Up to 3 years
Adverse Events
For any adverse reactions, the researchers refer to the National Cancer Institute (NCI) standard of common toxicity (CTC)
Measured: Up to 6 months
Surgery Morbidity
Surgical morbidity reported according to Clavien-Dindo classification
Measured: 30 days and 12-months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of Esophagogastric JunctionStudies of the same condition, open and under way.
- More trials run by Peking University 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YE Yingjiang, Peking University People's Hospital
- Investigators
- Yingjiang Ye, MD，PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505461
- Sponsor's protocol ID
- WCWKZL-001
- Acronym
- NICLA
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PD-1 Combined With Long-term Concurrent Neoadjuvant Chemoradiotherapy and Chemotherapy in the Treatment of Resectable Locally Advanced Esophagogastric Junction Adenocarcinoma： A Phase II Study
- ClinicalTrials.gov ID
- NCT05505461
- Acronym / sponsor ID
- NICLA / WCWKZL-001
- Keywords
- PD-1, neoadjuvant therapy, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Aug 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.
The purpose of this study was to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.
Detailed description
The incidence of adenocarcinoma of the esophagogastric junction (AEG) is increasing in Asian countries and Western Contries. Surgical resection is the most important treatment for AEG. However, the recurrence rate is high when surgery is performed alone. The results of CLASSIC, MAGIC, FLOT4, JCOG0501, PRODIGY, RESOLVE, CROSS trial showed that perioperative chemotherapy and pre- or postoperative chemoradiotherapy significantly increase the overall survival rate and disease free survival rate compared to surgery alone. Radiotherapy and immunotherapy can increase sensitivity to each other, and several clinical studies have also showed that PD-1 antibody may significantly prolongs the life.Thus the investigators plan to conduct this clinical trial to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.
Subjects will receive long-term radiotherapy (5w) concurrent with PD-1 antibody for 2 cycles, then receive two cycles of SOX regimen combined PD-1 after a week's rest. Surgery will be performed 2 weeks after the last cycle of neoadjuvant treatment. Adjuvant treatment will be started 3 to 8 weeks after surgery, and SOX regimen will be given for 4 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therpy | Experimental | Drug: neoadjuvant Radiation plus SOX and PD-1 antibodyNeoadjuvant chemoradiation plus SOX and PD-1 antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed adenocarcinoma of esophagogastric junction, and Her-2 negative.
- Clinically diagnosed stage T3+orN+M0, according to CT/MRI scan.
- No prior anti-tumor treatment, including surgery, chemotherapy, radiotherapy, and targeted therapy.
- Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1.
- At least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is required.
Key exclusion criteria (13 listed)
- Existence of other active malignant tumors within 5 years or at the same time.
- Already received chemotherapy, radiation therapy, targeted or immunotherapy.
- Have any active autoimmune disease or history of autoimmune disease.
- Patients with congenital or acquired immunodeficiency.
- Use of immunosuppressive drugs within 14 days before the study start.
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 |
|---|---|---|
| neoadjuvant Radiation plus SOX and PD-1 antibodyAlso: Neoadjuvant Chemoradiotherapy plus ImmunotherapyPatients will be given the perioperative treatment as below once recruited: First, neoradiation (5w) will be given: intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas. PD-1 antibody will be started concurrent the radiation for 2 cycles. The neochemotherapy (SOX) and PD-1 antibody will be given for 2 cycles after 1 week since radiation completed ; Patients will rest 2 weeks after the last cycle of neochemotherapy, and evaluation will be performed during this time. And D2 surgery will be performed if resectable. SOX and PD-1 antibody will be given q3w. Adjuvant chemotherapy: We advise starting 4 cycles of SOX regimen in 3-8w after surgery. | Drug | Neoadjuvant therpy |
Primary outcome
Pathological Complete Responce (pCR) Rate
Time frame: Up to 6 months
Proportion of patients with AEG who received neoadjuvant theray with radiation plus PD-1 antibody and SOX regimen and postoperative pathological examination shows pathological complete responce
4 secondary outcomes
R0 Resection Rate
Time frame: Up to 6 months
Progression Free Survival (PFS)
Time frame: Up to 3 years
Adverse Events
Time frame: Up to 6 months
Surgery Morbidity
Time frame: 30 days and 12-months after surgery
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 17 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Adenocarcinoma of Esophagogastric Junction
RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
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.
Yingjiang Ye, MD，PhD principal investigator
Peking University 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 neoadjuvant Radiation plus SOX and PD-1 antibody in people with Adenocarcinoma of Esophagogastric Junction, run by Peking University 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 12 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: opening soon, as of the sponsor's last update on 17 Aug 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?
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 Liyu Zhu, MD (+8610-66583821, wcwkzlward@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Responce (pCR) Rate (time frame: Up to 6 months). 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 17 Aug 2022.