Rectal CancerPhase 1/2NCT04558684
Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer
A Phase 1/2 study testing Chemotherapy, Immunotherapy and IMRT in people with Rectal Cancer and Radiotherapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a open-label, single-arm study to investigate the safety and efficacy of Total neoadjuvant chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy in patients with rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Radiotherapy, Immunotherapy
- What is being tested?
- Chemotherapy, Immunotherapy and IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 30 Dec 2023
- Phase
- Phase 1/2
- 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 personally provided written consent for participation in the study
- Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor is at a distance of 10 cm or less from the AV before CRT
- Histologically confirmed adenocarcinoma of rectum (non-metastatic, >T2N0 or low T2N0 rectal cancer) not eligible for up-front organ preservation surgery as deemed by multidisciplinary evaluation
- Patients with the ECOG performance status of 0 or 1 at the time of enrollment
- Women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy
- Male patients who consent to practicing contraception during the period from giving informed consent to at least 31 weeks after the last dose of the study drug
- Patients must have acceptable organ and marrow function as defined below:
- Absolute neutrophil count (ANC) >1,500/uL Hg > 8.0 g/dL; if blood transfusion is performed for achieving adequate hemoglobin level, the level should stay above goal for at least 1 week after transfusion Platelets >100,000/uL Total bilirubin <1.5X normal institutional limits aspartate aminotransferase (AST) (SGOT) / alanine aminotransferase (ALT)(SGPT) < 3X upper limit of normal Creatinine <1.5X upper limit of normal or creatinine clearance (CrCL)>50 by Cockcroft-Gault
Who cannot join
- Patients with recurrent rectal cancer or a history of pelvic radiation
- Patients with a history of inflammatory bowel disease
- Patients with a history of pneumonitis or interstitial lung disease
- Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
- Patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study
- Patients with a history of thyroid dysfunction
Show all 10Show fewer
- Patients with a history or finding of cardiovascular risk
- Patients who are positive for any of the following: HIV1 antibody, HIV2 antibody, HTLV1 antibody
- Patients who are pregnant or lactating or who may be pregnant
- Patients with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: Short Course Radiotherapy With Total Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer
This is a open-label, single-arm study to investigate the safety and efficacy of Total neoadjuvant chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy in patients with rectal cancer.
Read the detailed description
Patients with rectal cancer are assigned to receive preoperative 5 × 5 Gy irradiation over 5 days with total neoadjuvant chemotherapy and camrelizumab, an anti-PD-1 antibody drug. The Primary Objective is to assess clinical complete response of an organ preservation approach and the secondary objective to assess safety in all enrolled patients, local regrowth rate and other cancer specific outcomes (metastasis-free survival, colostomy-free survival and overall survival), longitudinal health-related quality of life of this organ preservation approach.
- Conditions
- Rectal Cancer, Radiotherapy, Immunotherapy, Organ Preservation
- Being tested
- Chemotherapy, Immunotherapy, IMRT
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
CAPOX (6 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine: Dose of 2000mg/m2,14 days, q3w
ImmunotherapyDrug
Camrelizumab (6 cycles): 200mg on day 1 of each cycle, q3w
IMRTRadiation
Radiotherapy (5 Gy x 5 fractions)
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy, chemotherapy and PD1 inhibitor | Experimental | Treatment will comprise 5 daily fractions of radiotherapy at 5 Gy per fraction followed by chemotherapy and immunotherapy. Those who achieve a clinical complete response will be considered for organ preservation approach. All other patients will receive standard surgery. Receives: Drug: Chemotherapy; Drug: Immunotherapy; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical complete response rate (cCR)
Proportion of patients who achieve a clinical complete response following treatment
Measured: 8 (+/-4 ) weeks
Secondary outcomes (4)
Local regrowth rate
Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology
Measured: 2 year
Disease free survival (DFS)
Five years disease-free survival of this group of patients
Measured: 5 year
Overall survival (OS)
Fives years overall survival of this group of patients
Measured: 5 year
Incidence of adverse events (AEs)
Incidence of adverse events will be assessed according to the latest "Clavien- Dindo Classification of surgical complications" and Common Terminology Criteria of Adverse Events (CTCAE).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Nov 2019
- Primary completion30 Sep 2020
- Study completion30 Dec 2023 (estimated)
Why it stopped: Inadequate patient enrollment
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 Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558684
- Sponsor's protocol ID
- WUGO-002
- Status last verified
- Dec 2023
- First submitted
- 16 Sep 2020
- Last updated
- 3 Jan 2024
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Course Radiotherapy With Total Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer
- ClinicalTrials.gov ID
- NCT04558684
- Acronym / sponsor ID
- WUGO-002
- Conditions
- Rectal Cancer, Radiotherapy, Immunotherapy, Organ Preservation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Inadequate patient enrollment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 Sep 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 open-label, single-arm study to investigate the safety and efficacy of Total neoadjuvant chemotherapy with camrelizumab, an anti-PD-1 antibody drug following short course radiotherapy in patients with rectal cancer.
Detailed description
Patients with rectal cancer are assigned to receive preoperative 5 × 5 Gy irradiation over 5 days with total neoadjuvant chemotherapy and camrelizumab, an anti-PD-1 antibody drug. The Primary Objective is to assess clinical complete response of an organ preservation approach and the secondary objective to assess safety in all enrolled patients, local regrowth rate and other cancer specific outcomes (metastasis-free survival, colostomy-free survival and overall survival), longitudinal health-related quality of life of this organ preservation approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiotherapy, chemotherapy and PD1 inhibitor | Experimental | Drug: Chemotherapy, Drug: Immunotherapy, Radiation: IMRTTreatment will comprise 5 daily fractions of radiotherapy at 5 Gy per fraction followed by chemotherapy and immunotherapy. Those who achieve a clinical complete response will be considered for organ preservation approach. All other patients will receive standard surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who personally provided written consent for participation in the study
- Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor is at a distance of 10 cm or less from the AV before CRT
- Histologically confirmed adenocarcinoma of rectum (non-metastatic, >T2N0 or low T2N0 rectal cancer) not eligible for up-front organ preservation surgery as deemed by multidisciplinary evaluation
- Patients with the ECOG performance status of 0 or 1 at the time of enrollment
- Women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy
Key exclusion criteria (10 listed)
- Patients with recurrent rectal cancer or a history of pelvic radiation
- Patients with a history of inflammatory bowel disease
- Patients with a history of pneumonitis or interstitial lung disease
- Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
- Patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study
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 |
|---|---|---|
| ChemotherapyCAPOX (6 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine: Dose of 2000mg/m2,14 days, q3w | Drug | radiotherapy, chemotherapy and PD1 inhibitor |
| ImmunotherapyCamrelizumab (6 cycles): 200mg on day 1 of each cycle, q3w | Drug | radiotherapy, chemotherapy and PD1 inhibitor |
| IMRTRadiotherapy (5 Gy x 5 fractions) | Radiation | radiotherapy, chemotherapy and PD1 inhibitor |
Primary outcome
Clinical complete response rate (cCR)
Time frame: 8 (+/-4 ) weeks
Proportion of patients who achieve a clinical complete response following treatment
4 secondary outcomes
Local regrowth rate
Time frame: 2 year
Disease free survival (DFS)
Time frame: 5 year
Overall survival (OS)
Time frame: 5 year
Incidence of adverse events (AEs)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chemotherapy, Immunotherapy and IMRT in people with Rectal Cancer and Radiotherapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 8 inclusion and 10 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: paused, as of the sponsor's last update on 3 Jan 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical complete response rate (cCR) (time frame: 8 (+/-4 ) weeks). 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 3 Jan 2024.