Locally Advanced Rectal CancerPhase 2NCT04411524
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer
A Phase 2 study testing PD-1 antibody, Capecitabine and Irinotecan in people with Locally Advanced Rectal Cancer, run by Fudan University at 1 site in China.
Trial summary
The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stability-high (MSI-H) locally advanced rectal cancer (LARC). Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- PD-1 antibody, Capecitabine and Irinotecan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Dec 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pathological confirmed adenocarcinoma
- clinical stage T3-4 and/or N+
- the distance from anal verge less than 12 cm
- without distance metastases
- age 18-70 years old, female and male
- KPS >=70
Show all 11Show fewer
- UGT1A1*28 6/6 or 6/7
- the MSI status is MSI-H or d-MMR
- without previous anti-cancer therapy or immunotherapy
- with good compliance
- signed the inform consent
Who cannot join
- pregnancy or breast-feeding women
- history of other malignancies within 5 years
- serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
- immunodeficiency disease or long-term using of immunosuppressive agents
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
- DPD deficiency
Show all 9Show fewer
- UGT1A1*28 7/7
- the MSI status is MSS or p-MMR
- allergic to any component of the therapy
Trial locations and contacts
1 site in 1 country.
China1 site
Zhen Zhang
Shanghai, Shanghai Municipality, 200032
Zhen Zhang, M.D, PH.D, 18801735029 ext. 18801735029, zhen_zhang@fudan.edu.cn
About this study
Official title: A Phase II Trial of Immunotherapy Combined With Neoadjuvant Chemoradiotherapy in Microsatellite Instability-High Locally Advanced Rectal Cancer
The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stability-high (MSI-H) locally advanced rectal cancer (LARC). A total of 50 MSI-H LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- PD-1 antibody, Capecitabine, Irinotecan, Neoadjuvant Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
Before neo-CRT: 2 cycles of PD-1 antibody After neo-CRT: 3 cycles of PD-1 antibody
CapecitabineDrug
Also called Xeloda
During neo-CRT: 625mg/m2 bid Monday-Friday per week
IrinotecanDrug
During neo-CRT: 80mg/m2 qw (UGT1A1*28 6/6) or 65mg/m2 qw (UGT1A1*28 6/7)
Neoadjuvant RadiotherapyRadiation
IMRT DT: 50Gy/25Fx
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | A total of 50 MSI-H LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. Receives: Drug: PD-1 antibody; Drug: Capecitabine; Drug: Irinotecan; Radiation: Neoadjuvant Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response Rate
Pathologic Complete Response Rate
Measured: The pathologic complete response rate was evaluated after surgery, which was scheduled 7-8 weeks after the end of chemoradiotherapy.
Secondary outcomes (8)
Disease free survival
3 year disease free survival rate
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Local recurrence free survival
3 year local recurrence free survival rate
Measured: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
Overall survival
3 year overall survival rate
Measured: From date of randomization until the date of death from any cause, assessed up to 36 months.
Adverse effects
Chemoradiation-related or immunotherapy-related adverse events
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years
Surgical complications
Surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Measured: The surgery was scheduled 7-8 weeks after the end of chemoradiotherapy. And the surgical complications were assessed up to 5 years from the surgery.
Performance Status (Zubrod-ECOG-WHO method), range 0-5. The higher scores mean a worse quality of life.
Quality of life will be evaluated
Measured: From date of randomization until the date of death from any cause, assessed up to 10 years
Karnofsky Performance Status, range 0-100. The higher scores mean a better quality of life.
Quality of life will be evaluated
Measured: From date of randomization until the date of death from any cause, assessed up to 10 years
Quality of Life Scale, range 0-60. It evaluates the quality of life from 12 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life.
Quality of life will be evaluated
Measured: From date of randomization until the date of death from any cause, assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Dec 2022 (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 Fudan UniversityThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
- Investigators
- Zhen Zhang, M.D, PH.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411524
- Sponsor's protocol ID
- FDRT-2019-104-1734
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 2 Jun 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 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Immunotherapy Combined With Neoadjuvant Chemoradiotherapy in Microsatellite Instability-High Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT04411524
- Acronym / sponsor ID
- FDRT-2019-104-1734
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Jun 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.
The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stability-high (MSI-H) locally advanced rectal cancer (LARC). A total of 50 MSI-H LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: PD-1 antibody, Drug: Capecitabine, Drug: Irinotecan, Radiation: Neoadjuvant RadiotherapyA total of 50 MSI-H LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- pathological confirmed adenocarcinoma
- clinical stage T3-4 and/or N+
- the distance from anal verge less than 12 cm
- without distance metastases
- age 18-70 years old, female and male
Key exclusion criteria (9 listed)
- pregnancy or breast-feeding women
- history of other malignancies within 5 years
- serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
- immunodeficiency disease or long-term using of immunosuppressive agents
- baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
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 antibodyBefore neo-CRT: 2 cycles of PD-1 antibody After neo-CRT: 3 cycles of PD-1 antibody | Drug | Treatment Arm |
| CapecitabineAlso: XelodaDuring neo-CRT: 625mg/m2 bid Monday-Friday per week | Drug | Treatment Arm |
| IrinotecanDuring neo-CRT: 80mg/m2 qw (UGT1A1*28 6/6) or 65mg/m2 qw (UGT1A1*28 6/7) | Drug | Treatment Arm |
| Neoadjuvant RadiotherapyIMRT DT: 50Gy/25Fx | Radiation | Treatment Arm |
Primary outcome
Pathologic Complete Response Rate
Time frame: The pathologic complete response rate was evaluated after surgery, which was scheduled 7-8 weeks after the end of chemoradiotherapy.
Pathologic Complete Response Rate
8 secondary outcomes
Disease free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Local recurrence free survival
Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months.
Adverse effects
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years
Surgical complications
Time frame: The surgery was scheduled 7-8 weeks after the end of chemoradiotherapy. And the surgical complications were assessed up to 5 years from the surgery.
Performance Status (Zubrod-ECOG-WHO method), range 0-5. The higher scores mean a worse quality of life.
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years
Karnofsky Performance Status, range 0-100. The higher scores mean a better quality of life.
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years
Quality of Life Scale, range 0-60. It evaluates the quality of life from 12 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life.
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 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.
Zhen Zhang, M.D, PH.D principal investigator
Fudan University
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 Irinotecan in people with Locally Advanced Rectal Cancer, run by Fudan University 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 11 inclusion and 9 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 2 Jun 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 Zhen Zhang, M.D, PH.D (18801735029 ext. 18801735029, zhen_zhang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response Rate (time frame: The pathologic complete response rate was evaluated after surgery, which was scheduled 7-8 weeks after the end of chemoradiotherapy.). 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 2 Jun 2020.