Gastroesophageal Junction Adenocarcinoma (Siewert II-III)Phase 2NCT06163729
Camrelizumab Combined With Chemotherapy and Radiotherapy Perioperative Treatment of Esophageal Gastric Junction Adenocarcinoma
A Phase 2 study testing Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy in people with Gastroesophageal Junction Adenocarcinoma (Siewert II-III), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Junction Adenocarcinoma (Siewert II-III)
- What is being tested?
- Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2022to 1 May 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged from 18 to 80 years old;
- Patients with pathologically confirmed gastroesophageal junction adenocarcinoma (Siewert II-III)
- Resectable tumors with staging t3-4N0M0 or T1-4N+M0 confirmed by CT or MRI according to AJCC version 8 staging System;
- Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
- No prior anti-tumor therapy, including surgery, chemotherapy, radiotherapy, targeted and immunotherapy;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
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- Estimated life expectancy of more than 3 months;
- Adequate haematological, hepatic and renal functions defined by the protocol;
- Prior use of anti-tumor traditional Chinese medicine, proprietary Chinese medicine, immunomodulators (such as thymosin, interleukin, etc.) must be ≥2 weeks from the beginning of the study
- Negative blood pregnancy test at Screening for women of childbearing potential; Highly effective contraception for both male and female subjects if the risk of conception exists;
- The subjects participated in the study voluntarily, fully understood and informed the study and signed the informed consent;
Who cannot join
- Previous malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)；
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
- Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
- Active tuberculosis;
- Prior organ transplantation, including allogeneic stem-cell transplantation；
- Other protocol-defined inclusion/exclusion criteria could apply.
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- Used immunosuppressive drugs within 14 days before the first dose of study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids;
- Accination with live or live/attenuated viruses within 4 weeks of the first dose of camrelizumab and while on trial is prohibited except for administration of inactivated vaccines;
- History of uncontrolled intercurrent illness including hypertension, active infection, diabetes , hereditary bleeding , coagulopathy with a risk of bleedingor, cardiac diseases or symptoms;
- Patients with past and current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-associated pneumonia, and severe impaired lung function may interfere with the detection and management of suspected drug-associated pulmonary toxicity;
- Known history of allergy to the drug components of this regimen;
- Presence of unresectable factors, including tumor, contraindications to surgery, or rejection of surgery;
- Major surgical procedures were performed within 4 weeks prior to initial administration;
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
Shugeng Gao
Beijing, Beijing Municipality, 100020
Shugeng Gao, Vice president
About this study
Official title: A Single-arm, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemotherapy Followed by Radiotherapy in the Perioperative Treatment of Gastroesophageal Junction Adenocarcinoma
This project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG.
Read the detailed description
The incidence of Adenocarcinoma of esophagogastric junction (AEG) is increasing in recent years. According to the statistics of The National Cancer Center of Japan, the proportion of AEG in gastric adenocarcinoma increased from 2.3% in the middle of the 20th century to 10.3% in the beginning of this century, and the proportion of Siewert II in AEG increased from 28.5% to 57.3%. Due to the special biological characteristics of tumor in this region, its definition and surgical treatment principles are controversial.
For AEG, the clinical study results of neoadjuvant chemoradiotherapy + surgery + chemotherapy showed that the tumor stage could be reduced, R0 resection could be improved and overall survival could be improved, without increasing postoperative complications and mortality. Long-term follow-up results from the German TRIAL III of preoperative chemoradiotherapy for AEG (POET) showed that preoperative chemoradiotherapy reduced recurrence (5y-local recurrence: 21% vs. 38%) and prolonged survival (3y-OS: 46.7% vs. 26.1%), without a significant increase in treatment toxicity and perioperative complications . Although some patients with AEG were included in the resolve 、 prodigy and resolution study ,and the total population could benefit from postoperative adjuvant radiotherapy and chemotherapy, but it was uncertain whether the patients with AEG could benefit in Asia.
Therefore, this project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG.
- Being tested
- Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapyDrug
Durg：Camrelizumab: 200mg, iv, d1, q3w Durg ：Oxaliplatin, 100mg/m2 , iv, d1, q3w Durg ：Paclitaxel(Albumin Bound), 125mg/m2, iv, d1, d8, q3w； Durg ：Radiotherapy, PGTV：45.1Gy/2.05Gy/ 22f； PTV：40.04Gy/1.82Gy/ 22f；Five days a week for more than four weeks
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy | Experimental | Not described Receives: Drug: Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (PCR)
pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects,achieving complete histological regression with no available tumor cells yT0N
Measured: 4 weeks after surgery
Secondary outcomes (5)
3 years-Overall Survival (3y-OS)
Percentage of patients who survived 3 years after the start of randomized treatment
Measured: up to 3 years
years-Event free survival (3y-EFS)
Proportion of patients with event-free survival at 3 years after randomization
Measured: up to 3 years
Disesease free survival（DFS）
Proportion of patients with disease-free survival at 3 years after randomization
Measured: up to 3 years
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
Measured: From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 1 years
R0 resection rate
R0 resection rate is defined as the percentage of patients, relative to the total of enrolled subjects, undergoing R0 resection of primary tumour
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start25 Aug 2022
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Junction Adenocarcinoma (Siewert II-III)Studies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shugeng Gao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163729
- Sponsor's protocol ID
- 22-OBU-BJ-GC-II-009
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 2 Feb 2024
- Results posted
- 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemotherapy Followed by Radiotherapy in the Perioperative Treatment of Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06163729
- Acronym / sponsor ID
- 22-OBU-BJ-GC-II-009
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 11 Dec 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.
This project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG.
Detailed description
The incidence of Adenocarcinoma of esophagogastric junction (AEG) is increasing in recent years. According to the statistics of The National Cancer Center of Japan, the proportion of AEG in gastric adenocarcinoma increased from 2.3% in the middle of the 20th century to 10.3% in the beginning of this century, and the proportion of Siewert II in AEG increased from 28.5% to 57.3%. Due to the special biological characteristics of tumor in this region, its definition and surgical treatment principles are controversial.
For AEG, the clinical study results of neoadjuvant chemoradiotherapy + surgery + chemotherapy showed that the tumor stage could be reduced, R0 resection could be improved and overall survival could be improved, without increasing postoperative complications and mortality. Long-term follow-up results from the German TRIAL III of preoperative chemoradiotherapy for AEG (POET) showed that preoperative chemoradiotherapy reduced recurrence (5y-local recurrence: 21% vs. 38%) and prolonged survival (3y-OS: 46.7% vs. 26.1%), without a significant increase in treatment toxicity and perioperative complications . Although some patients with AEG were included in the resolve 、 prodigy and resolution study ,and the total population could benefit from postoperative adjuvant radiotherapy and chemotherapy, but it was uncertain whether the patients with AEG could benefit in Asia.
Therefore, this project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy | Experimental | Drug: Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects aged from 18 to 80 years old;
- Patients with pathologically confirmed gastroesophageal junction adenocarcinoma (Siewert II-III)
- Resectable tumors with staging t3-4N0M0 or T1-4N+M0 confirmed by CT or MRI according to AJCC version 8 staging System;
- Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
- No prior anti-tumor therapy, including surgery, chemotherapy, radiotherapy, targeted and immunotherapy;
Key exclusion criteria (13 listed)
- Previous malignant disease within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)；
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
- Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
- Active tuberculosis;
- Prior organ transplantation, including allogeneic stem-cell transplantation；
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 |
|---|---|---|
| Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapyDurg：Camrelizumab: 200mg, iv, d1, q3w Durg ：Oxaliplatin, 100mg/m2 , iv, d1, q3w Durg ：Paclitaxel(Albumin Bound), 125mg/m2, iv, d1, d8, q3w； Durg ：Radiotherapy, PGTV：45.1Gy/2.05Gy/ 22f； PTV：40.04Gy/1.82Gy/ 22f；Five days a week for more than four weeks | Drug | Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy |
Primary outcome
Pathologic complete response (PCR)
Time frame: 4 weeks after surgery
pCR rate is defined as the percentage of patients, relative to the total of enrolled subjects,achieving complete histological regression with no available tumor cells yT0N
5 secondary outcomes
3 years-Overall Survival (3y-OS)
Time frame: up to 3 years
years-Event free survival (3y-EFS)
Time frame: up to 3 years
Disesease free survival（DFS）
Time frame: up to 3 years
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Time frame: From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 1 years
R0 resection rate
Time frame: 24 months
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 2 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Gastroesophageal Junction Adenocarcinoma (Siewert II-III)
Recruiting
Safety and Short-term Outcomes of Modular Robotic System for Siewert II/III Gastroesophageal Junction Cancer
Siewert Type II/III Gastroesophageal Junction Adenocarcinoma
Not yet recruitingObservational study
Molecular Characterization of Tumor-Microenvironment Interactions to Predict Drug Resistance in Gastric and GEJ Adenocarcinoma
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma (Siewert II-III)
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.
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+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy in people with Gastroesophageal Junction Adenocarcinoma (Siewert II-III), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 11 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: looking for participants now, as of the sponsor's last update on 2 Feb 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 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 Yong Li, chief physician (010-87788052, liyongdoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (PCR) (time frame: 4 weeks after surgery). 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 2 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.