Locally Advanced Rectal CancerPhase 2NCT04663763
Neoadjuvant Short-course Radiotherapy Followed by the Combination of Immunotherapy and Chemotherapy in Locally Advanced Rectal Cancer
A Phase 2 study testing PD-1 antibody, Capecitabine and Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This is a single arm, open-label, prospective phase II clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and immunotherapy (PD-1 antibody) for patients with locally advanced rectal cancer (LARC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- PD-1 antibody, Capecitabine and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2025
- 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
- 1. Pathological confirmed rectal adenocarcinoma and the distance from anal verge less than 12 cm;
- 2. Clinical stage T3-4 and/or N+ (AJCC 8th);
- 3. No distant metastases;
- 4. Age 18-70 years old, female and male;
- 5. ECOG 0-1;
- 6. No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment;
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- 7. Adequate organ function defined at baseline as:
- ANC ≥1.5×109 /L，PLt ≥75×109 /L，Hb ≥90 g/L;
- TBIL ≤1.5×ULN, ALT ≤2.5ULN, AST ≤2.5ULN, BUN and Cr ≤1×ULN or Ccr ≥50ml/min (Cockcroft-Gault formula);
- INR ≤1.5×ULN or PT ≤1.5×ULN (If the patient is receiving anticoagulant therapy, PT should be within the intended use range of the anticoagulant drug);
- 8. With good compliance and no serious comorbidity;
- 9. Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative;
- 10. Subject volunteers to join the study, sign the informed consent.
Who cannot join
- 1. History of other uncured malignancies within 5 years. Cured tumor with good prognosis, such as skin basal cell carcinoma, cervical cancer and superficial bladder cancer, will be excluded;
- 2. Have received surgery within 4 weeks before the enrollment;
- 3. History of obstruction within 6 months before the enrollment;
- 4. History of active autoimmune disease, interstitial lung disease, epilepsy and dysphrenia;
- 5. With uncontrolled cardiovascular disease: active coronary heart disease; grade III-IV cardiac insufficiency according to the NYHA criteria; and myocardial infarction within 1 year;
- 6. With active infection or fever of >38.5 ℃ with unknown cause (tumor-induced fever judged could be enrolled);
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- 7. DPD deficiency;
- 8. Allergic to any component of chemotherapy or immunotherapy;
- 9. With congenital or acquired immunodeficiency (such as those with HIV infection), active hepatitis B or hepatitis C;
- 10. Usage of corticosteroids (prednison dose of > 10 mg/day) or other immunosuppressors for systemic treatment within the first 14 days of research;
- 11. Receive attenuated live vaccine within 4 weeks before the research;
- 12. Pregnant women or breast-feeding women;
- 13. With other factors that would force to terminate the clinical trial ahead of time, such as the development of other severe comorbidity that required combined treatment, and family or social factors affecting the safety of patients or experimental data collection, as judged by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 571
Yuping Zhu, MD, 86-0571-88128011, drzyp@163.com
Yibo Cai, MD, 86-0571-88128011, caiyiyibo@zju.edu.cn
About this study
Official title: The Combination of Neoadjuvant Short-course Radiotherapy and Immunotherapy in Locally Advanced Rectal Cancer：A Open-label Single-arm Phase II Trial.
This is a single arm, open-label, prospective phase II clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and immunotherapy (PD-1 antibody) for patients with locally advanced rectal cancer (LARC). A total of 40 patients will be enrolled in this trial to receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 4 cycles of CAPOX chemotherapy. There are two cohorts according to the microsatellite instability status: (1) the micro-satellite stable (MSS) cohort（n=32), (2) the MSI-high cohort (n=8). The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- PD-1 antibody, Capecitabine, Oxaliplatin
- Keywords
- Neoadjuvant short-course radiotherapy, Immunotherapy, Locally advanced rectal cancer, Pathological complete response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
Also called Sintilimab
Sintilimab is a humanized IgG4 monoclonal antibody against the programmed death-1 (PD-1) receptor. Usage: 200mg ivgtt d1 q3w.
CapecitabineDrug
Usage: 1000mg/m2 d1-14 q3w
OxaliplatinDrug
Usage: 130mg/m2 d1 q3w
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant short-course radiotherapy+immunotherapy+chemotherapy | Experimental | A total of 40 patients receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery and another 4 cycles of CAPOX chemotherapy.
Interventions:
Shor-course radiotherapy: 25Gy/5Fx;
Induction immunotherapy: Sintilimab 200mg ivgtt d1 q3w x 4 cycles;
Concurrent Chemotherapy: Oxaliplatin: 130mg/m2 d1 q3w + Capecitabine: 1000mg/m2 d1-14 q3w x 4 cycles; Receives: Drug: PD-1 antibody; Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
Pathologic complete response rate
Measured: The TME surgery will be recommended at 1 week after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months
Secondary outcomes (6)
3-year DFS
3-year disease free survival rate
Measured: Assessed up to 3 years
3-year local recurrence rate
3-year local recurrence rate
Measured: Assessed up to 3 years
3-year OS
3-year overall survival rate
Measured: Assessed up to 3 years
Grade 3-4 adverse effects rate
Radiotherapy, immunotherapy and chemotherapy related grade 3-4 adverse events rate
Measured: Assessed up to 3 years
Surgical complications
Type and Rate of surgical complications
Measured: Assessed up to 3 years from the TME surgery
Quality of Life Scale
The Quality of Life Scale (QoLS, range 0-60) will be used to evaluate the quality of life. Higher scores mean the better quality of life
Measured: Assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuping Zhu, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663763
- Sponsor's protocol ID
- IRB-2020-336
- Status last verified
- Dec 2020
- First submitted
- 28 Nov 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Neoadjuvant Short-course Radiotherapy and Immunotherapy in Locally Advanced Rectal Cancer：A Open-label Single-arm Phase II Trial.
- ClinicalTrials.gov ID
- NCT04663763
- Acronym / sponsor ID
- IRB-2020-336
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Neoadjuvant short-course radiotherapy, Immunotherapy, Locally advanced rectal cancer, Pathological complete response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Dec 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 single arm, open-label, prospective phase II clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and immunotherapy (PD-1 antibody) for patients with locally advanced rectal cancer (LARC). A total of 40 patients will be enrolled in this trial to receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 4 cycles of CAPOX chemotherapy. There are two cohorts according to the microsatellite instability status: (1) the micro-satellite stable (MSS) cohort（n=32), (2) the MSI-high cohort (n=8). The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant short-course radiotherapy+immunotherapy+chemotherapy | Experimental | Drug: PD-1 antibody, Drug: Capecitabine, Drug: OxaliplatinA total of 40 patients receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery and another 4 cycles of CAPOX chemotherapy. Interventions: Shor-course radiotherapy: 25Gy/5Fx; Induction immunotherapy: Sintilimab 200mg ivgtt d1 q3w x 4 cycles; Concurrent Chemotherapy: Oxaliplatin: 130mg/m2 d1 q3w + Capecitabine: 1000mg/m2 d1-14 q3w x 4 cycles; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Pathological confirmed rectal adenocarcinoma and the distance from anal verge less than 12 cm;
- 2. Clinical stage T3-4 and/or N+ (AJCC 8th);
- 3. No distant metastases;
- 4. Age 18-70 years old, female and male;
- 5. ECOG 0-1;
Key exclusion criteria (13 listed)
- 1. History of other uncured malignancies within 5 years. Cured tumor with good prognosis, such as skin basal cell carcinoma, cervical cancer and superficial bladder cancer, will be excluded;
- 2. Have received surgery within 4 weeks before the enrollment;
- 3. History of obstruction within 6 months before the enrollment;
- 4. History of active autoimmune disease, interstitial lung disease, epilepsy and dysphrenia;
- 5. With uncontrolled cardiovascular disease: active coronary heart disease; grade III-IV cardiac insufficiency according to the NYHA criteria; and myocardial infarction within 1 year;
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 |
|---|---|---|
| PD-1 antibodyAlso: SintilimabSintilimab is a humanized IgG4 monoclonal antibody against the programmed death-1 (PD-1) receptor. Usage: 200mg ivgtt d1 q3w. | Drug | Neoadjuvant short-course radiotherapy+immunotherapy+chemotherapy |
| CapecitabineUsage: 1000mg/m2 d1-14 q3w | Drug | Neoadjuvant short-course radiotherapy+immunotherapy+chemotherapy |
| OxaliplatinUsage: 130mg/m2 d1 q3w | Drug | Neoadjuvant short-course radiotherapy+immunotherapy+chemotherapy |
Primary outcome
pCR rate
Time frame: The TME surgery will be recommended at 1 week after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months
Pathologic complete response rate
6 secondary outcomes
3-year DFS
Time frame: Assessed up to 3 years
3-year local recurrence rate
Time frame: Assessed up to 3 years
3-year OS
Time frame: Assessed up to 3 years
Grade 3-4 adverse effects rate
Time frame: Assessed up to 3 years
Surgical complications
Time frame: Assessed up to 3 years from the TME surgery
Quality of Life Scale
Time frame: Assessed up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Yuping Zhu, MD principal investigator
Zhejiang Cancer 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 PD-1 antibody, Capecitabine and Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Zhejiang Cancer 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 13 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: status not confirmed, as of the sponsor's last update on 11 Dec 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 Yuping Zhu, MD (86-0571-88128011, drzyp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: The TME surgery will be recommended at 1 week after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 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 11 Dec 2020.