Gastric AdenocarcinomaPhase 2Neo-PLANETNCT03631615
Neoadjuvant Chemoradiation Plus PD-1 Antibody(SHR-1210) in Locally Advanced Proximal Stomach Adenocarcinoma
A Phase 2 study testing Neoadjuvant chemoradiation plus PD-1 antibody(SHR-1210) in people with Gastric Adenocarcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
1. Target population: patients with resectable locally advanced proximal (including gastroesophageal junction, fundus and upper body) stomach adenocarcinoma (cT3-4aN+M0). 2. Primary objective: pathological complete remission (pCR) rate of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) in patients with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Neoadjuvant chemoradiation plus PD-1 antibody(SHR-1210)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2018to Dec 2020
- 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
- histologically documented gastric adenocarcinoma.
- primary lesion is in proximal stomach, including gastroesophageal junction, fundus and upper body.
- clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan.
- at least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is required.
- surgeons participating in this study consider the lesion a resectable one.
- Karnofsky score≥ 80.
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- Physical condition and adequate organ function to ensure the success of abdominal surgery.
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
- Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence of liver metastases, or < 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
- Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
- No serious concomitant disease that will threaten the survival of patients to less than 5 years.
- Male or female. Age ≥ 18 years and ≤75 years.
- Written (signed) informed consent.
- Good compliance with the study procedures, including lab and auxiliary examination and treatment.
- Female patients should not be pregnant or breast feeding.
- Agree to take contraception measures during treatment and in 120 days after last dose of SHR-1210 or in 180 days after last dose of chemo.
Who cannot join
- patients with distant metastasis or unresectable primary lesion.
- patients with T1, T2 lesion according to CT/MRI or ultrasound endoscopy.
- history of chemo, radiation, immune therapy or radical resection for the stomach adenocarcinoma, except steroids.
- patients with active autoimmune disease or history of refractory autoimmune disease.
- patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ.
- uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment.
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- patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding.
- perforation / fistula of GI tract in 6 months before recruitment.
- patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of capecitabine.
- losing over 20% body weight in 2 months before recruitment.
- pulmonary disease history: interstitial pulmonary disease, non-infective pneumonitis, pulmonary fibrosis, acute pulmonary disease.
- uncontrollable systemic diseases, including diabetes, hypertension, etc.
- severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB or HIV, etc.
- patients with untreated chronic hepatitis B or HBV DNA over 500 IU/ml or positive HCV RNA.
- patients with any cardiovascular risk factors below:
- cardiac chest pain occurring in 28 days before recruitment, defined as moderate pain that limits daily activity.
- pulmonary embolism with symptoms occurring in 28 days before recruitment.
- acute myocardial infarction occurring in 6 months before recruitment.
- any history of heart failure reaching grade 3/4 of NYHA in 6 months before recruitment.
- ventricular arrhythmias of Grade 2 or grater in 6 months before recruitment, or accompanied by supraventricular tachyarrhythmias requiring medical treatment.
- cerebrovascular accident within 6 months before recruitment.
- patients with peripheral neuropathy NCI CTC AE grade 1, except those with only deep tendon reflex disappearing.
- moderate or severe renal injury [creatinine clearance rate≤50 ml/min (according to Cockroft \& Gault equation)], or Scr>ULN.
- dipyrimidine dehydrogenase (DPD) deficiency.
- allergic to any drug in this study.
- history of allogeneic stem cell transplantation or organ transplantation.
- use of steroids (dosage>10mg/d prednisone) or other systemic immune suppressive therapy in 14 days before recruitment, except patients treated with regimens below: a. steroids for hormone replacement (dosage>10mg/d prednisone); b. steroids for local application with little systemic absorption; c. short -term (≤ 7 days) steroids for preventing allergy or vomiting.
- vaccinated with live vaccine in 4 weeks before recruitment.
- receiving immune (interleukin, interferon, thymin) treatment or treatment of other trials in 28 days before recruitment.
- receiving palliative radiation in 14 days before recruitment.
- history of anti PD-1, PD-L1, PD-L2 or any other specific T cell co-stimulation or checkpoint pathway targeted treatment.
- receiving operation in 28 days before recruitment, only if the operation is a minimally invasive one e.g. PICC.
- for patients with uncontrolled epilepsy, CNS diseases or history of mental disorder, researchers should evaluate whether their diseases will impede their signing of informed consent or compliance of treatment.
- existing of potential situation which will impede drug administration or affect toxicity analysis or alcohol/ drug abuse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu, Doctor, liu.tianshu@zs-hospital.sh.cn
Yiyi Yu, master
About this study
Official title: A Phase II Study of Neoadjuvant Chemoradiation Plus PD-1 Antibody(SHR-1210) in the Locally Advanced Proximal Stomach Adenocarcinoma (Neo-PLANET)
- Target population: patients with resectable locally advanced proximal (including gastroesophageal junction, fundus and upper body) stomach adenocarcinoma (cT3-4aN+M0).
- Primary objective: pathological complete remission (pCR) rate of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) in patients with locally advanced proximal stomach adenocarcinoma.
Secondary objectives:
Read more
- pathological remission rate (pRR) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
- objective response rate (ORR) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
- progression free survival (PFS)/ overall survival (OS) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
- safety of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
3.Trial design: This is a monocenter, single arm, phase II study to evaluate the efficacy and safety of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) in patients with locally advanced proximal stomach adenocarcinoma.
4.Treatment plan:
Patients will be given the perioperative treatment as below once recruited:
- induction chemotherapy (3w): one cycle of XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1, Q21d);
- within one week after the induction, concurrent chemoradiation will be started (5w): intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas, total dose:45Gy/25d, 1.8Gy/d, capecitabine (850 mg/m2, bid, po) will be given during radiotherapy as sensitizer.
- consolidation chemotherapy will be started in 2-3w after concurrent chemoradiation: one cycle of XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1, Q21d); From the beginning of induction chemo to 3w before surgery, PD-1 antibody SHR-1210 will be given（200mg, iv, q3w).
Re-evaluation will be conducted in 1-3w after consolidation chemo, resectable patients will receive D2 resection.
Adjuvant chemo: We advice starting 4 cycles of XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1, Q21d) in 4-6w after surgery.
5.Number of subjects: 36 patients. Number of centers: 1 sites ( Fudan University Affiliated Zhongshan Hospital, which has high volume of gastric operations in China, more than 500 per year).
Read the detailed description
Backgrounds:
SHR-1210 is a PD-1 antibody developed by Jiangsu Heng Rui Medicine Co. Nowadays, fifteen clinical trials of this drug have been conducted in patients with different types of advanced malignant tumor, including one combined with radiotherapy and three combined with chemotherapy. Until now, SHR-1210 has exhibited favorable safety in recruited patients. Incidence rate of SAE is only 1%.
Several big scale clinical research like POET, RTOG 9904 and TOPGEAR have proofed the efficacy and safety of neoadjuvant chemoradiation in treating locally advanced GEJ cancer or gastric cancer.
Study design:
This clinical trial will be conducted under Simon's optimal two-stage design. The first stage needs 15 participants, if ≥1 participants acquire remission, then the study will move on to the second stage and enroll the rest 21 participants. The total sample size will be 36 patients.
We will shut down the study in advance, if situations below happens: 1) 1 treatment related death, >3 disease progression or >2 hyper-progressive disease happen during the first stage; 2) 2 treatment related death, >6 disease progression or >4 hyper-progressive disease happen during the whole study.
Patients with abnormal autoimmune status, unfavorable body function, factors impeding drug taking, absorption and metabolism will be excluded. Study participants with disease progression or severe/ intolerant toxicity during treatment will withdraw the study.
Hyper-progressive disease is defined as 1) progression 2) more than doubled growth rate 3) tumor volume increase >50% in 2 months after initialing the treatment.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Neoadjuvant chemoradiation plus PD-1 antibody(SHR-1210)
- Keywords
- neoadjuvant chemoradiation, PD-1 antibody(SHR-1210), locally advanced proximal stomach adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemoradiation plus PD-1 antibody(SHR-1210)Drug
Also called Newplan
Patients will be given the perioperative treatment as below once recruited:
- induction Neochemotherapy (3w): one cycle of XELOX regimen before surgery;
- within one week after the induction, concurrent neochemoradiation will be started (5w): intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas.
- consolidation neochemotherapy will be started in 2-3w after concurrent chemoradiation: one cycle of XELOX regimen; From the beginning of induction chemo to 3w before surgery, PD-1 antibody SHR-1210 will be given q3W.
Re-evaluation will be conducted in 1-3w after consolidation chemo, resectable patients will receive D2 resection.
Adjuvant chemo: We advise starting 4 cycles of XELOX regimen in 4-6w after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therpy | Experimental | neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) Receives: Drug: Neoadjuvant chemoradiation plus PD-1 antibody(SHR-1210) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete remission (pCR) rate of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) in patients with locally advanced proximal stomach adenocarcinoma.
rate of patients with no residual tumor lesion (Grade 3) in surgical specimen
Measured: 5 months after the last subject participating in
Secondary outcomes (5)
pathological remission rate (pRR) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
rate of patients with < 2/3 residual tumor lesion (Grade 1b, 2, 3) in surgical specimen compared to baseline
Measured: 5 months after the last subject participating in
objective response rate (ORR) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1. ORR was evaluated by chest, abdominal \& pelvic CT/MRI. Evaluation will be conducted on 9w\&15w during preoperative treatment, every 6 weeks during adjuvant XELOX, and every 0.5 year after all treatments.
Measured: 36 months after the last subject participating in
progression free survival (PFS) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
PFS is defined as time interval from recruitment to tumor progression or censoring. Tumor progression is defined as below: 1) relapse of primary lesion 2) emerging of new lesion 3) distant metastasis 4) death of any reason 5)tumor progression according to RESIST 1.1 on CT/MRI.
Measured: 36 months after the last subject participating in
overall survival (OS) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
OS is defined as time interval from recruitment to all-caused death or censoring.
Measured: 36 months after the last subject participating in
safety of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
Adverse events (AE) of chemo- and radio-therapy will be graded and documented according to NCI-CTC AE v4.03 from the beginning of treatment to 1 months after the last date of treatment. Documentary will include severity, lasting period and occurrence time. Main AEs include vomiting, diarrhea, anemia, leukopenia, thrombocytopenia, hand-foot syndrome, epidermal capillary hyperplasia, immune related adverse events (including pneumonia, interstitial lung disease, AST/ALT elevations, rash, diarrhea, hypothyroidism and hyperthyroidism) and hyper-progressive tumor.
AEs of surgery refer to complications which happen during or in 30 days after operation. Severe complications after operation such as abdominal or GI tract bleeding, anastomotic fistula, pancreatic fistula of grade B or above, incision complications (infection, bleeding, rupture) will be observed and classified by Clavien-Dindo grading.
Measured: 1 month after the last date of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start20 Aug 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Tianshu Liu, Shanghai Zhongshan Hospital
- Investigators
- Tianshu Liu, Doctor, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631615
- Sponsor's protocol ID
- SHR-1210-CRT-GC-IIT
- Acronym
- Neo-PLANET
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2018
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Chemoradiation Plus PD-1 Antibody(SHR-1210) in the Locally Advanced Proximal Stomach Adenocarcinoma (Neo-PLANET)
- ClinicalTrials.gov ID
- NCT03631615
- Acronym / sponsor ID
- Neo-PLANET / SHR-1210-CRT-GC-IIT
- Conditions
- Gastric Adenocarcinoma
- Keywords
- neoadjuvant chemoradiation, PD-1 antibody(SHR-1210), locally advanced proximal stomach adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Aug 2018 (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.
- Target population: patients with resectable locally advanced proximal (including gastroesophageal junction, fundus and upper body) stomach adenocarcinoma (cT3-4aN+M0).
- Primary objective: pathological complete remission (pCR) rate of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) in patients with locally advanced proximal stomach adenocarcinoma.
Secondary objectives:
- pathological remission rate (pRR) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
- objective response rate (ORR) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
- progression free survival (PFS)/ overall survival (OS) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
- safety of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
3.Trial design: This is a monocenter, single arm, phase II study to evaluate the efficacy and safety of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) in patients with locally advanced proximal stomach adenocarcinoma.
4.Treatment plan:
Patients will be given the perioperative treatment as below once recruited:
- induction chemotherapy (3w): one cycle of XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1, Q21d);
- within one week after the induction, concurrent chemoradiation will be started (5w): intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas, total dose:45Gy/25d, 1.8Gy/d, capecitabine (850 mg/m2, bid, po) will be given during radiotherapy as sensitizer.
- consolidation chemotherapy will be started in 2-3w after concurrent chemoradiation: one cycle of XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1, Q21d); From the beginning of induction chemo to 3w before surgery, PD-1 antibody SHR-1210 will be given（200mg, iv, q3w).
Re-evaluation will be conducted in 1-3w after consolidation chemo, resectable patients will receive D2 resection.
Adjuvant chemo: We advice starting 4 cycles of XELOX regimen (capecitabine 1000 mg/m2 bid*14d + oxaliplatin 130mg/m2, d1, Q21d) in 4-6w after surgery.
5.Number of subjects: 36 patients. Number of centers: 1 sites ( Fudan University Affiliated Zhongshan Hospital, which has high volume of gastric operations in China, more than 500 per year).
Detailed description
Backgrounds:
SHR-1210 is a PD-1 antibody developed by Jiangsu Heng Rui Medicine Co. Nowadays, fifteen clinical trials of this drug have been conducted in patients with different types of advanced malignant tumor, including one combined with radiotherapy and three combined with chemotherapy. Until now, SHR-1210 has exhibited favorable safety in recruited patients. Incidence rate of SAE is only 1%.
Several big scale clinical research like POET, RTOG 9904 and TOPGEAR have proofed the efficacy and safety of neoadjuvant chemoradiation in treating locally advanced GEJ cancer or gastric cancer.
Study design:
This clinical trial will be conducted under Simon's optimal two-stage design. The first stage needs 15 participants, if ≥1 participants acquire remission, then the study will move on to the second stage and enroll the rest 21 participants. The total sample size will be 36 patients.
We will shut down the study in advance, if situations below happens: 1) 1 treatment related death, >3 disease progression or >2 hyper-progressive disease happen during the first stage; 2) 2 treatment related death, >6 disease progression or >4 hyper-progressive disease happen during the whole study.
Patients with abnormal autoimmune status, unfavorable body function, factors impeding drug taking, absorption and metabolism will be excluded. Study participants with disease progression or severe/ intolerant toxicity during treatment will withdraw the study.
Hyper-progressive disease is defined as 1) progression 2) more than doubled growth rate 3) tumor volume increase >50% in 2 months after initialing the treatment.
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 chemoradiation plus PD-1 antibody(SHR-1210)neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- histologically documented gastric adenocarcinoma.
- primary lesion is in proximal stomach, including gastroesophageal junction, fundus and upper body.
- clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan.
- at least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is required.
- surgeons participating in this study consider the lesion a resectable one.
Key exclusion criteria (34 listed)
- patients with distant metastasis or unresectable primary lesion.
- patients with T1, T2 lesion according to CT/MRI or ultrasound endoscopy.
- history of chemo, radiation, immune therapy or radical resection for the stomach adenocarcinoma, except steroids.
- patients with active autoimmune disease or history of refractory autoimmune disease.
- patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ.
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 chemoradiation plus PD-1 antibody(SHR-1210)Also: NewplanPatients will be given the perioperative treatment as below once recruited: 1. induction Neochemotherapy (3w): one cycle of XELOX regimen before surgery; 2. within one week after the induction, concurrent neochemoradiation will be started (5w): intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas. 3. consolidation neochemotherapy will be started in 2-3w after concurrent chemoradiation: one cycle of XELOX regimen; From the beginning of induction chemo to 3w before surgery, PD-1 antibody SHR-1210 will be given q3W. Re-evaluation will be conducted in 1-3w after consolidation chemo, resectable patients will receive D2 resection. Adjuvant chemo: We advise starting 4 cycles of XELOX regimen in 4-6w after surgery. | Drug | Neoadjuvant therpy |
Primary outcome
pathological complete remission (pCR) rate of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) in patients with locally advanced proximal stomach adenocarcinoma.
Time frame: 5 months after the last subject participating in
rate of patients with no residual tumor lesion (Grade 3) in surgical specimen
5 secondary outcomes
pathological remission rate (pRR) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
Time frame: 5 months after the last subject participating in
objective response rate (ORR) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
Time frame: 36 months after the last subject participating in
progression free survival (PFS) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
Time frame: 36 months after the last subject participating in
overall survival (OS) of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
Time frame: 36 months after the last subject participating in
safety of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210)
Time frame: 1 month after the last date of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 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.
Tianshu Liu, Doctor principal investigator
Shanghai Zhongshan 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 chemoradiation plus PD-1 antibody(SHR-1210) in people with Gastric Adenocarcinoma, run by Shanghai Zhongshan 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 17 inclusion and 34 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 26 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianshu Liu, Doctor (+861368 1973 996, liu.tianshu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete remission (pCR) rate of neoadjuvant chemoradiation plus PD-1 antibody (SHR-1210) in patients with locally advanced proximal stomach adenocarcinoma. (time frame: 5 months after the last subject participating in). 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 26 Aug 2020.