Rectal CancerPhase 2NCT04340401
Total Neoadjuvant Treatment Plus SHR1210 for High-risk Rectal Cancer and Biomarker Screening Base on Neoantigen
A Phase 2 study testing SHR-1210, Oxaliplatin and Capecitabine in people with Rectal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is designed to test the efficacy and safety of Total Neoadjuvant Treatment plus SHR1210（an anti-PD-1 Inhibitor) for High-risk locally advanced Rectal Cancer, Meanwhile, screening effective Biomarker base on neoantigen. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- SHR-1210, Oxaliplatin and Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2020to Apr 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤70 years.
- ECOG Performance status 0-1.
- Histologically confirmed diagnosis of adenocarcinoma of the rectum.
- The distance from down verge of tumor to anal-rectal junction (ARJ) ≤8cm, or ≤12 cm based on sigmoidoscopy.
- Clinical Stage T3c, T3d, T4a or T4b, or EMVI (+) or mrN2 or MRF (+) based on MRI.
- No evidence of distant metastases.
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- No prior pelvic radiation therapy.
- No prior chemotherapy or surgery for rectal cancer.
- No active infections requiring systemic antibiotic treatment.
- No systemic infection requiring antibiotic treatment.
- No immune system disease.
- ANC > 1.5 cells/mm3, HGB > 9.0 g/dL, PLT > 100,000/mm3, total bilirubin≤ 1.5×ULN, AST≤ 2.5×ULN, ALT ≤ 2.5×ULN.
- Serum creatinine is within 1.5 times the physiological range， creatinine clearance rate≥50 ml/min
- Patients with controllable hypertension were included.
- Patients who did not receive anticoagulant therapy: INR, aPTT is required to be within the 1.5 times the physiological range;Patients who receive anticoagulant therapy: INR, aPTT is required to be within the physiological range.
- FT3, FT4, TSH are Normal or abnormal without clinical significance.
- ECG examination is Normal or abnormal without clinical significance; Echocardiography shows that LVEF>50%.
- Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
- Patients show good adherence, follow -up on time. It is recommended that all patients provide tumor tissue samples (preferably fresh tissue samples) for pathological genetic testing prior to enrollment.
- Fertile men or women with potential for pregnancy must use highly effective contraception throughout the trial. And continue contraception for 12 months after treatment ends.
Who cannot join
- Recurrent rectal cancer.
- Anticipated unresectable tumor after neoadjuvant treatment.
- Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
- Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
- Other Anticancer or Experimental Therapy.
- Women who are pregnant or breast-feeding.
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- Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
- Patients with a history of anti-PD-1, anti-PD-L1, anti-PD-L2 or CEGFR TKI therapy.
- Patients underwent major surgery or had not recovered from the side effects of this surgery, received a vaccine, received immunotherapy within 4 weeks before the first use of the study drug, and received radiotherapy within 2 weeks.
- Patients who received hematopoietic stimulating factors therapy, such as G-CSF and erythropoietin, within 1 week before the first administration of the study drug.
- Patients are allergic to study medication and its ingredients.
- Patients have active lung disease (such as interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or active tuberculosis.
- Patients have any uncontrollable clinical problems, including but not limited to:
- Persistent or severe infection.
- Hypertension that can't be effectively controlled by drugs（ blood pressure reading of 150 over 90）.
- Uncontrolled diabetes
- Heart disease (Class III / IV congestive heart failure or cardiac block as defined by the New York Heart Association)
- Patient has or is suspected of having an autoimmune disease,Such as pituitary inflammation, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.
- Patients have other serious, acute or chronic diseases or have abnormal test results, and the investigator judges that this may increase the patient's risk of participating in the trial or interfere with the results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
Yingjie Li, M.D., +86 135 2018 6618, liyingjiedr@sina.com
Aiwen Wu, M.D.
About this study
Official title: A Phase II Study of Total Neoadjuvant Chmoradiation Treatment Plus SHR1210 for High-risk Locally Advanced Rectal Cancer and Biomarker Screening Base on Neoantigen
This study is designed to test the efficacy and safety of Total Neoadjuvant Treatment plus SHR1210（an anti-PD-1 Inhibitor) for High-risk locally advanced Rectal Cancer, Meanwhile, screening effective Biomarker base on neoantigen.
Read the detailed description
The combined treatment model of neoadjuvant chemoradiotherapy treatment + radical rectal resection + adjuvant therapy has become the standard treatment model for locally advanced mid-low rectal cancer, However, the existing evidence shows that this comprehensive treatment method has reached the upper limit of efficacy and cannot continue to reduce the metastatic rate and improve the survival rate.
Recent studies have shown that PD-1 antibody inhibitors have excellent curative effects on the treatment of a variety of tumors and have good safety.
This study is a single-arm, single-center, prospective, phase II clinical study. It is designed to test the efficacy and safety of Total Neoadjuvant chmoradiation Treatment plus SHR1210 for High-risk locally advanced Rectal Cancer, Meanwhile, screening effective Biomarker base on neoantigen.
In this study, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision.
This study is designed to recruit 25 patients in all.
- Conditions
- Rectal Cancer
- Being tested
- SHR-1210, Oxaliplatin, Capecitabine, Intensity modulated radiotherapy, Total mesorectal excision
- Keywords
- High-risk locally advanced Rectal cancer, SHR-1210, Total Neoadjuvant chmoradiation Treatment, pCR rate
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Drug
Also called Camrelizumab
Patients will receive 3 cycles induction CapeOX and SHR-1210
OxaliplatinDrug
Also called OXA
CapeOX is a combination chemotherapy regimen with OXA and CAPE, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision.
CapecitabineDrug
Also called CAPE
CapeOX is a combination chemotherapy regimen with OXA and CAPE, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision.
Intensity modulated radiotherapyRadiation
Also called IMRT
patients will receive intensity modulated radiotherapy with capecitabine
Total mesorectal excisionProcedure or surgery
Also called TME
Patients will receive TME (Total mesorectal excision) following TNT+SHR1210 if no metastasis occurs.
| Study group | Role | What they receive |
|---|---|---|
| TNT+SHR1210 | Experimental | Patients with high-risk locally advanced rectal cancer will receive chemotherapy and SHR-1210 before chemoradiaton, after chemoradiaton, patient will receive consolidation chemotherapy. This arm is called Total Neoadjuvant Treatment (TNT) plus SHR-1210. The neoadjuvant chemotherapy regimen is designed as 3 cycles of CapeOX ( Capecitabine + Oxaliplatin ) plus SHR-1210 over a period of approximately 8 weeks. Tumor response will be evaluated after chemotherapy. Then patients will undergo 22f-IMRT (Intensity modulated radiotherapy) with capecitabine. Patients will receive two more cycles of consolidation CapeOX if tolerable when there was no progressed disease in induction CapeOX.
Finally, patients will receive TME (Total mesorectal excision) following TNT+SHR1210 if no metastasis occurs. Receives: Drug: SHR-1210; Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Intensity modulated radiotherapy; Procedure: Total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response rate(pCR rate)
The number of patients with pCR divided by the total number of patients
Measured: 1 month after surgery
Secondary outcomes (5)
Toxicity of TNT+SHR-1210
Category and grade of adverse event during neoadjuvant chemotherapy
Measured: 90 days after neoadjuvant treatment
Change of TCR repertoire
Use neoantigen model to find biomarkers related to the effect of TNT+SHR1210 for patients with rectal cancer; compare and analyze the differences in TCR repertoire changes in peripheral blood.
Measured: 1 week before surgery
Disease-free survival (DFS)
The 3-year DFS will be defined as the percentage of patients alive without local recurrence or distant metastasis of disease at 3 years measured from the date of the administration of treatment.
Measured: 3 years
Surgical complication rate
Rate of patients who had surgical complications during the perioperative period
Measured: 30 days after surgery
Major adverse events
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Measured: 90 days after the last use of SHR-1210
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start25 May 2020
- Primary completionJul 2020 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiwen Wu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340401
- Sponsor's protocol ID
- PKUCH-R04
- Status last verified
- Jul 2020
- First submitted
- 6 Apr 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Total Neoadjuvant Chmoradiation Treatment Plus SHR1210 for High-risk Locally Advanced Rectal Cancer and Biomarker Screening Base on Neoantigen
- ClinicalTrials.gov ID
- NCT04340401
- Acronym / sponsor ID
- PKUCH-R04
- Conditions
- Rectal Cancer
- Keywords
- High-risk locally advanced Rectal cancer, SHR-1210, Total Neoadjuvant chmoradiation Treatment, pCR rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 9 Apr 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 study is designed to test the efficacy and safety of Total Neoadjuvant Treatment plus SHR1210（an anti-PD-1 Inhibitor) for High-risk locally advanced Rectal Cancer, Meanwhile, screening effective Biomarker base on neoantigen.
Detailed description
The combined treatment model of neoadjuvant chemoradiotherapy treatment + radical rectal resection + adjuvant therapy has become the standard treatment model for locally advanced mid-low rectal cancer, However, the existing evidence shows that this comprehensive treatment method has reached the upper limit of efficacy and cannot continue to reduce the metastatic rate and improve the survival rate.
Recent studies have shown that PD-1 antibody inhibitors have excellent curative effects on the treatment of a variety of tumors and have good safety.
This study is a single-arm, single-center, prospective, phase II clinical study. It is designed to test the efficacy and safety of Total Neoadjuvant chmoradiation Treatment plus SHR1210 for High-risk locally advanced Rectal Cancer, Meanwhile, screening effective Biomarker base on neoantigen.
In this study, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision.
This study is designed to recruit 25 patients in all.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNT+SHR1210 | Experimental | Drug: SHR-1210, Drug: Oxaliplatin, Drug: Capecitabine, Radiation: Intensity modulated radiotherapy, Procedure: Total mesorectal excisionPatients with high-risk locally advanced rectal cancer will receive chemotherapy and SHR-1210 before chemoradiaton, after chemoradiaton, patient will receive consolidation chemotherapy. This arm is called Total Neoadjuvant Treatment (TNT) plus SHR-1210. The neoadjuvant chemotherapy regimen is designed as 3 cycles of CapeOX ( Capecitabine + Oxaliplatin ) plus SHR-1210 over a period of approximately 8 weeks. Tumor response will be evaluated after chemotherapy. Then patients will undergo 22f-IMRT (Intensity modulated radiotherapy) with capecitabine. Patients will receive two more cycles of consolidation CapeOX if tolerable when there was no progressed disease in induction CapeOX. Finally, patients will receive TME (Total mesorectal excision) following TNT+SHR1210 if no metastasis occurs. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 18 years and ≤70 years.
- ECOG Performance status 0-1.
- Histologically confirmed diagnosis of adenocarcinoma of the rectum.
- The distance from down verge of tumor to anal-rectal junction (ARJ) ≤8cm, or ≤12 cm based on sigmoidoscopy.
- Clinical Stage T3c, T3d, T4a or T4b, or EMVI (+) or mrN2 or MRF (+) based on MRI.
Key exclusion criteria (19 listed)
- Recurrent rectal cancer.
- Anticipated unresectable tumor after neoadjuvant treatment.
- Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
- Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
- Other Anticancer or Experimental Therapy.
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 |
|---|---|---|
| SHR-1210Also: CamrelizumabPatients will receive 3 cycles induction CapeOX and SHR-1210 | Drug | TNT+SHR1210 |
| OxaliplatinAlso: OXACapeOX is a combination chemotherapy regimen with OXA and CAPE, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision. | Drug | TNT+SHR1210 |
| CapecitabineAlso: CAPECapeOX is a combination chemotherapy regimen with OXA and CAPE, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision. | Drug | TNT+SHR1210 |
| Intensity modulated radiotherapyAlso: IMRTpatients will receive intensity modulated radiotherapy with capecitabine | Radiation | TNT+SHR1210 |
| Total mesorectal excisionAlso: TMEPatients will receive TME (Total mesorectal excision) following TNT+SHR1210 if no metastasis occurs. | Procedure or surgery | TNT+SHR1210 |
Primary outcome
pathologic complete response rate(pCR rate)
Time frame: 1 month after surgery
The number of patients with pCR divided by the total number of patients
5 secondary outcomes
Toxicity of TNT+SHR-1210
Time frame: 90 days after neoadjuvant treatment
Change of TCR repertoire
Time frame: 1 week before surgery
Disease-free survival (DFS)
Time frame: 3 years
Surgical complication rate
Time frame: 30 days after surgery
Major adverse events
Time frame: 90 days after the last use of SHR-1210
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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.
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 SHR-1210, Oxaliplatin and Capecitabine in people with Rectal Cancer, run by Peking University Cancer Hospital & Institute 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 20 inclusion and 19 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 9 Jul 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 Yingjie LI (+86 135 2018 6618, liyingjie@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response rate(pCR rate) (time frame: 1 month 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 9 Jul 2020.