Gastric CancerPhase 2NCT04631757
Conversion Therapy of Camrelizumab Plus Chemoradiotherapy in Participants With Initial Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
A Phase 2 study testing Camrelizumab + SOX + Radiotherapy in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This is a study of Camrelizumab in Combination With concurrent radiotherapy and SOX for Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Camrelizumab + SOX + Radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2020to 31 Dec 2023
- 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
- Patients who provided written informed consent to be subjects in this trial.
- 18-75 years old.
- Has histologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
- The initial unresectable or potentially resectable locally advanced proximal gastric carcinoma /Gastroesophageal Junction (GEJ) Adenocarcinoma (Siewert type II/III) in clinical stage T3-4N+M0 (AJCC 8 edition TNM stage) under any following condition: serious primary tumor invasion, unresectable bulky lymph node, retroperitoneal lymph node metastasis (RPLM). Clinical staging was performed according to enhanced CT/MRI examination.
- No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (include but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy)
- Plan to have surgery after conversion therapy.
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- Patients capable of taking oral medication.
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Survival expectation ≥12 months.
- Adequate organ function according to the following laboratory test results: absolute neutrophil count (ANC) ≥1.5×109/L; platelets ≥80×109/L; hemoglobin ≥90g/L; total bilirubin ≤1.5 ULN; serum creatinine ≤1.5 ULN or measured or calculated creatinine clearance > 50ml/min.
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication and must be willing to use an adequate method of contraception for the course of the study through 90 days after the last dose of study medication. Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy.
Who cannot join
- HER2 positive subjects will be excluded.
- With evidence of abdominal metastases.
- Has a known additional malignancy that is progressing within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
- The presence of any of the following cardiac clinical symptoms or diseases: New York Heart Association (NYHA) congestive heart failure of grade II or above, LVEF<50%, unstable angina pectoris, myocardial infarction within the past 12 months, QTc ≥ 450ms for male, QTc ≥ 450ms for female, electrocardiogram (ECG) examination revealed clinically significant abnormalities, have factors that increase the risk of prolonged QTc and abnormal heart rhythm.
- With active infection requiring drug intervention (e.g. anti-bacterial drugs, antiviral drugs, antifungal drugs treatment).
- Patients with active hepatitis B (HBsAg positive and HBV DNA≥500 IU/ml), hepatitis C (HCV antibodies positive and HCV RNA copies > ULN)
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- With congenital immune deficiency or human immunodeficiency virus (HIV) infection.
- Plan to receive or have previously received an organ or allogeneic bone marrow transplant.
- Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc; active tuberculosis (TB).
- Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease.
- Who has received immunosuppressants/systemic corticosteroids therapy < 7 days before the first dose for an immunosuppression purpose (> 10mg/day prednisone or other equivalency drugs).
- Has received a live vaccine within 28 days prior to the first dose, plan to receive a live vaccine during or within 60 days after study treatment.
- Have any contraindications for study treatment.
- Participate in other clinical trials within 4 weeks before the first dose.
- Is pregnant or breastfeeding.
- Patients were judged unsuitable as subjects of this trial by investigators.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Non-randomized, Phase II Study of Camrelizumab in Combination With Concurrent Chemoradiotherapy for Initial Unresectable Proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Conversion Therapy
This is a study of Camrelizumab in Combination With concurrent radiotherapy and SOX for Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Patients without prior palliative therapy will be treated with Camrelizumab, radiotherapy (total 45 Gy), Oxaliplatin, and S-1. The primary endpoint is the 1-year PFS rate.
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of Camrelizumab plus Concomitant Chemoradiotherapy in patients with Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. 33 participants with Initial Unresectable locally advanced proximal gastric carcinoma /Gastroesophageal Junction (GEJ) Adenocarcinoma (Siewert type II/III) will be treated with conversion therapy as below once recruited:
- induction chemotherapy (3w): one cycle of camrelizumab 200mg q3w and SOX regimen (oxaliplatin 130mg/m2, d1, Q3w + S-1 40-60mg bid, d1-d14,Q3w);
- after the induction, concurrent Chemoradiotherapy will be started (5-6w): intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas, total dose:45Gy/25d, 1.8Gy/d, camrelizumab 200mg q3w, S-1 40-60mg bid, d1-d14, Q3w. The resectability assessment will be performed followed by MDT.
- Participants still unresectable will receive additional conversion therapy with camrelizumab and SOX regimen. The resectability will be evaluated every 6 weeks until resectable or up to 8 cycles of conversion therapy.
Resectable patients will receive D2 resection.
- Conditions
- Gastric Cancer
- Being tested
- Camrelizumab + SOX + Radiotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab + SOX + RadiotherapyDrug
Camrelizumab 200mg,d1,Q3w; oxaliplatin 130mg/m2, d1, Q3w; S-1 40-60mg bid, d1-d14,Q3w; intensity modulated radiotherapy 45Gy/25d
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab plus Chemoradiotherapy | Experimental | Patients with initial unresectable proximal gastric or gastroesophageal junction (GEJ) adenocarcinoma will receive camrelizumab 200mg q3w, SOX regimen (oxaliplatin 130mg/m2, d1, Q3w + S-1 40-60mg bid, d1-d14, Q3w), and intensity modulated radiotherapy for tumors and high-risk lymphatic drainage areas (45Gy/25d). Resectable patients after conversion therapy will receive D2 resection. Receives: Drug: Camrelizumab + SOX + Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year progression-free survival (PFS) rate according to RECIST 1.1 base on investigator assessment
PFS was defined as the time from the first dose to the first documented disease progression per RECIST 1.1 based on investigator assessment. PFS rate at 1 year as estimated by Kaplan-Meier method.
Measured: Up to approximately 12 months
Secondary outcomes (7)
progression-free survival (PFS) according to RECIST 1.1 base on investigator assessment
PFS was defined as the time from the first dose to the first documented disease progression per RECIST 1.1 based on investigator assessment.
Measured: Up to approximately 36 months
disease-free survival (DFS) Per RECIST 1.1 base on investigator assessment
DFS is defined as the time from post-surgery baseline scan until the first occurrence of local/distant recurrence or death from any cause and is based on RECIST 1.1 as assessed by investigators in patients undergoing surgery.
Measured: Up to approximately 36 months
rate of R0-resections
the percentage of participants undergoing surgery with resection margin status negative.
Measured: Up to 30 days post-sugery
Major pathological response（MPR）
The proportion of participants with a major pathological response (mPR) at the time of definitive surgery.
Measured: Up to 30 days post-sugery
Pathological Complete Response (pCR)
Pathological complete response (pCR) is measured as the proportion of participants with a pathological complete response at the time of definitive surgery.
Measured: Up to 30 days post-sugery
Overall Survival (OS)
OS is the time from the first dose to death due to any cause.
Measured: Up to 5 years
Percentage of Participants Experiencing An Adverse Event (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocolspecified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received. The grade of AE will be assessed per CTCAE 5.0.
Measured: Up to approximately12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start15 Dec 2020 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631757
- Sponsor's protocol ID
- MA-GC-II-006
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Phase II Study of Camrelizumab in Combination With Concurrent Chemoradiotherapy for Initial Unresectable Proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Conversion Therapy
- ClinicalTrials.gov ID
- NCT04631757
- Acronym / sponsor ID
- MA-GC-II-006
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Nov 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 of Camrelizumab in Combination With concurrent radiotherapy and SOX for Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Patients without prior palliative therapy will be treated with Camrelizumab, radiotherapy (total 45 Gy), Oxaliplatin, and S-1. The primary endpoint is the 1-year PFS rate.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of Camrelizumab plus Concomitant Chemoradiotherapy in patients with Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. 33 participants with Initial Unresectable locally advanced proximal gastric carcinoma /Gastroesophageal Junction (GEJ) Adenocarcinoma (Siewert type II/III) will be treated with conversion therapy as below once recruited:
- induction chemotherapy (3w): one cycle of camrelizumab 200mg q3w and SOX regimen (oxaliplatin 130mg/m2, d1, Q3w + S-1 40-60mg bid, d1-d14,Q3w);
- after the induction, concurrent Chemoradiotherapy will be started (5-6w): intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas, total dose:45Gy/25d, 1.8Gy/d, camrelizumab 200mg q3w, S-1 40-60mg bid, d1-d14, Q3w. The resectability assessment will be performed followed by MDT.
- Participants still unresectable will receive additional conversion therapy with camrelizumab and SOX regimen. The resectability will be evaluated every 6 weeks until resectable or up to 8 cycles of conversion therapy.
Resectable patients will receive D2 resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab plus Chemoradiotherapy | Experimental | Drug: Camrelizumab + SOX + RadiotherapyPatients with initial unresectable proximal gastric or gastroesophageal junction (GEJ) adenocarcinoma will receive camrelizumab 200mg q3w, SOX regimen (oxaliplatin 130mg/m2, d1, Q3w + S-1 40-60mg bid, d1-d14, Q3w), and intensity modulated radiotherapy for tumors and high-risk lymphatic drainage areas (45Gy/25d). Resectable patients after conversion therapy will receive D2 resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who provided written informed consent to be subjects in this trial.
- 18-75 years old.
- Has histologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
- The initial unresectable or potentially resectable locally advanced proximal gastric carcinoma /Gastroesophageal Junction (GEJ) Adenocarcinoma (Siewert type II/III) in clinical stage T3-4N+M0 (AJCC 8 edition TNM stage) under any following condition: serious primary tumor invasion, unresectable bulky lymph node, retroperitoneal lymph node metastasis (RPLM). Clinical staging was performed according to enhanced CT/MRI examination.
- No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (include but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy)
Key exclusion criteria (16 listed)
- HER2 positive subjects will be excluded.
- With evidence of abdominal metastases.
- Has a known additional malignancy that is progressing within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
- The presence of any of the following cardiac clinical symptoms or diseases: New York Heart Association (NYHA) congestive heart failure of grade II or above, LVEF<50%, unstable angina pectoris, myocardial infarction within the past 12 months, QTc ≥ 450ms for male, QTc ≥ 450ms for female, electrocardiogram (ECG) examination revealed clinically significant abnormalities, have factors that increase the risk of prolonged QTc and abnormal heart rhythm.
- With active infection requiring drug intervention (e.g. anti-bacterial drugs, antiviral drugs, antifungal drugs treatment).
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 + SOX + RadiotherapyCamrelizumab 200mg,d1,Q3w; oxaliplatin 130mg/m2, d1, Q3w; S-1 40-60mg bid, d1-d14,Q3w; intensity modulated radiotherapy 45Gy/25d | Drug | Camrelizumab plus Chemoradiotherapy |
Primary outcome
1-year progression-free survival (PFS) rate according to RECIST 1.1 base on investigator assessment
Time frame: Up to approximately 12 months
PFS was defined as the time from the first dose to the first documented disease progression per RECIST 1.1 based on investigator assessment. PFS rate at 1 year as estimated by Kaplan-Meier method.
7 secondary outcomes
progression-free survival (PFS) according to RECIST 1.1 base on investigator assessment
Time frame: Up to approximately 36 months
disease-free survival (DFS) Per RECIST 1.1 base on investigator assessment
Time frame: Up to approximately 36 months
rate of R0-resections
Time frame: Up to 30 days post-sugery
Major pathological response（MPR）
Time frame: Up to 30 days post-sugery
Pathological Complete Response (pCR)
Time frame: Up to 30 days post-sugery
Overall Survival (OS)
Time frame: Up to 5 years
Percentage of Participants Experiencing An Adverse Event (AEs)
Time frame: Up to approximately12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab + SOX + Radiotherapy in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital.
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 16 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 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaona Wang, M.D. (+86 18622221089, xiaonawang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year progression-free survival (PFS) rate according to RECIST 1.1 base on investigator assessment (time frame: Up to approximately 12 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 Nov 2020.