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New treatment option for Gastroesophageal Junction Adenocarcinoma (Siewert II-III)
Official title Camrelizumab Combined With Chemotherapy and Radiotherapy Perioperative Treatment of Esophageal Gastric Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT06163729
What this study is testing
What is Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy?
Camrelizumab+Oxaliplatin+Paclitaxel (Albumin Bound) +radiotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastroesophageal junction adenocarcinoma (siewert ii-iii).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Male or female people 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;
You likely can't join if
- 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...
- Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis...
- Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU /...
- Active tuberculosis;
- Prior organ transplantation, including allogeneic stem-cell transplantation；
- Other protocol-defined inclusion/exclusion criteria could apply.
See the full eligibility criteria
- Male or female people 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;
- 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 people if the risk of conception exists;
- The people participated in the study voluntarily, fully understood and informed the study and signed the informed consent;
- 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...
- 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...
- Active tuberculosis;
- Prior organ transplantation, including allogeneic stem-cell transplantation；
- Other protocol-defined inclusion/exclusion criteria could apply.
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.