Colorectal CancerPhase 2NCT06516445
SCRT Followed by Camrelizumab Combined With Fluzoparib and Chemotherapy as Neoadjuvant Therapy for LARC
A Phase 2 study testing SCRT, Camrelizumab and Fluzoparib in people with Colorectal Cancer, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
To explore the safety and efficacy of neoadjuvant therapy for locally advanced rectal cancer with short course radiotherapy followed by camrelizumab combined with fluzoparib and chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- SCRT, Camrelizumab and Fluzoparib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2023to 28 Jun 2026
- 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
- Patients who provided written informed consent form for participation in this study;
- Aged 18-75 years old, male or female;
- Histologically confirmed pathological diagnosis of proficient mismatch repair/microsatellite stable(pMMR/MSS) rectal adenocarcinoma;
- The lower margin of the tumor is ≤10cm from the anal verge;
- Clinical Stage (according to the 8th edition of AJCC) T3NanyM0 and confirmed on imaging to fulfil at least any of the following: （1）MRF (+)，（2）EMVI（+），（3）LPLN（+）；or T4NanyM0 with or without one of the above three;
- Those who are expected to achieve R0 resection;
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- Able to swallow tablets normally;
- Patients with the ECOG performance status of 0 or 1 at the time of enrollment;
- Patients have not received any previous anti-tumor therapy for rectal cancer;
- Planning to undergo surgery after completion of neoadjuvant therapy;
- Have no contraindications to surgery;
- Normal function of major organs, including:
- Routine blood tests (no blood components, cell growth factors, leukocyte boosters, platelet boosters, or anaemia-correcting drugs will be allowed within 14 days prior to the first dose of study drug):White blood cell count ≥ 4.0 x 109/L; Neutrophil count ≥ 1.5 x 109/L; Platelet count ≥100×109/L; Hemoglobin ≥90 g/L
- Blood biochemistry: Total bilirubin ≤ 1.5 x ULN; ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN; Serum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥ 50 mL/min (Cocheroft-Gault formula)
- Coagulation: International normalised ratio (INR) ≤ 1.5 x ULN; Activated partial thromboplastin time (APTT) ≤ 1.5×ULN
- Female subjects of childbearing potential are required to have a negative serum pregnancy test within 72 hours prior to initiation of study drug administration and to use effective contraception (e.g., intrauterine device, birth control pills, or condoms) during the trial period and for at least 3 months after the last dose of study drug; for male subjects whose partner is a female of childbearing potential, effective contraception should be used during the trial period and for 3 months after the last dose of study drug; and for male subjects whose partner is a female of childbearing potential, effective contraception should be used during the trial period and for 3 months after the last dose of study drug. Use effective contraception;
Who cannot join
- A pre-existing history of allergy to monoclonal antibodies, any component of camrelizumab, fluzoparib, capecitabine, oxaliplatin, or other platinum-based drugs;
- Has received, or is receiving, any of the following prior treatments：a) Any radiotherapy, chemotherapy, or other antineoplastic drug directed against the tumor; b) Treatment with immunosuppressive drugs, or systemic hormonal drugs for immunosuppression (doses > 10 mg/day prednisone or equivalent) within 2 weeks prior to first use of study drug; inhaled or topical steroids and adrenocorticotropic hormone replacement at doses > 10 mg/day prednisone or equivalent are permissible in the absence of active autoimmune disease; c) Received a live attenuated vaccine within 4 weeks prior to first use of study drug; d) Major surgery or severe trauma within 4 weeks prior to first use of study drug;
- Any active autoimmune disease or history of autoimmune disease including, but not limited to: interstitial pneumonitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies that have been in complete remission and do not require any intervention in adulthood may be considered for inclusion, but patients requiring bronchial Medical intervention with bronchodilators may not be included;
- A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
- Presence of cardiac clinical conditions or diseases that are not well controlled, including, but not limited to, such as (1) NYHA Class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmia that is not clinically intervened with or that remains poorly controlled after clinical intervention;
- A serious infection (CTCAE > grade 2) within 4 weeks prior to first use of study drug, such as severe pneumonia, bacteremia, or infectious co-morbidities requiring hospitalisation; except for prophylactic antibiotics if baseline chest imaging suggests active lung inflammation, signs and symptoms of infection within 14 days prior to first use of study drug, or if oral or intravenous antibiotic therapy is required ;
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- The presence of active tuberculosis infection by history or CT scan, or a history of active tuberculosis infection within 1 year prior to enrolment, or a history of active tuberculosis infection more than 1 year ago without regular treatment
- Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV RNA above the lower detection limit of the analytical method);
- Other malignancies diagnosed within 5 years prior to the first use of study drug, unless malignancies with a low risk of metastasis or risk of death (5-year survival >90%), such as adequately treated basal cell carcinoma of the skin or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix, may be considered for enrolment;
- Women during pregnancy or lactation;
- In the judgement of the investigator, the presence of other factors that may lead to forced termination of the study in the middle of the study, such as the presence of other serious illnesses (including psychiatric illnesses) that require comorbid treatment, alcoholism, drug abuse, family or social factors that may affect the safety of or compliance with the subject.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430079
xianglin yuan
About this study
Official title: A Clinical Study of Short Course Radiotherapy (SCRT) Followed by Camrelizumab Combined With Fluzoparib and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
To explore the safety and efficacy of neoadjuvant therapy for locally advanced rectal cancer with short course radiotherapy followed by camrelizumab combined with fluzoparib and chemotherapy
- Conditions
- Colorectal Cancer
- Being tested
- SCRT, Camrelizumab, Fluzoparib, CAPEOX
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCRTRadiation
5×5Gy，5Gy/d，QD，D1-D5
CamrelizumabDrug
200mg, D1, ivgtt, Q3W, C1-4
FluzoparibDrug
100mg, BID, PO, Q3W, C1-4
CAPEOXDrug
Capecitabine: 1000 mg/m2, BID, PO，D1-14, Q3W, C1-C4； Oxaliplatin: 130mg/m2, D1, ivgtt, 0-2h，Q3W，C1-4
| Study group | Role | What they receive |
|---|---|---|
| SCRT followed by camrelizumab combined with fluzoparib and chemotherapy | Experimental | Not described Receives: Radiation: SCRT; Drug: Camrelizumab; Drug: Fluzoparib; Drug: CAPEOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence and grade according to NCI-CTCAE 5.0(including serious adverse events and immune-related adverse events); Surgical safety: surgical complications, 30 - and 90-day postoperative mortality, length of stay, and reoperation rate
Measured: up to 36 months
pCR (Pathological Complete Response)
The proportion of subjects with no residual viable tumor cells(ypT0N0) in the primary tumor and lymph nodes, also defined as the proportion of subjects with grade 0 in the AJCC Tumor Regression Grading (TRG) scoring system(version 8.0).
Measured: up to 6 months
Secondary outcomes (6)
3-year Event-Free Survival(EFS) rate
The percentage of patients without disease recurrence or progression or death due to any cause after 3-year follow-up
Measured: up to 36 months
Overall Survival(OS)
The time from the date of randomization to the death caused by any cause
Measured: up to 36 months
R0 resection rate
The rate of negative margin microscopically
Measured: up to 6 months
Completion rate of neoadjuvant therapy
the rate of NAT completion
Measured: up to 6 months
Tumor Regression grade (TRG)
Evaluated according to AJCC Version 8 TRG scoring system
Measured: up to 6 months
quality of life (QOL)
The EORTC QLQ-C30 scale was used
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start28 Jun 2023
- Primary completion28 Jun 2025 (estimated)
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516445
- Sponsor's protocol ID
- MA-CRC-II-007
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 24 Jul 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Short Course Radiotherapy (SCRT) Followed by Camrelizumab Combined With Fluzoparib and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT06516445
- Acronym / sponsor ID
- MA-CRC-II-007
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 28 Jun 2025 (estimated)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 24 Jul 2024 (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.
To explore the safety and efficacy of neoadjuvant therapy for locally advanced rectal cancer with short course radiotherapy followed by camrelizumab combined with fluzoparib and chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCRT followed by camrelizumab combined with fluzoparib and chemotherapy | Experimental | Radiation: SCRT, Drug: Camrelizumab, Drug: Fluzoparib, Drug: CAPEOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients who provided written informed consent form for participation in this study;
- Aged 18-75 years old, male or female;
- Histologically confirmed pathological diagnosis of proficient mismatch repair/microsatellite stable(pMMR/MSS) rectal adenocarcinoma;
- The lower margin of the tumor is ≤10cm from the anal verge;
- Clinical Stage (according to the 8th edition of AJCC) T3NanyM0 and confirmed on imaging to fulfil at least any of the following: （1）MRF (+)，（2）EMVI（+），（3）LPLN（+）；or T4NanyM0 with or without one of the above three;
Key exclusion criteria (11 listed)
- A pre-existing history of allergy to monoclonal antibodies, any component of camrelizumab, fluzoparib, capecitabine, oxaliplatin, or other platinum-based drugs;
- Has received, or is receiving, any of the following prior treatments：a) Any radiotherapy, chemotherapy, or other antineoplastic drug directed against the tumor; b) Treatment with immunosuppressive drugs, or systemic hormonal drugs for immunosuppression (doses > 10 mg/day prednisone or equivalent) within 2 weeks prior to first use of study drug; inhaled or topical steroids and adrenocorticotropic hormone replacement at doses > 10 mg/day prednisone or equivalent are permissible in the absence of active autoimmune disease; c) Received a live attenuated vaccine within 4 weeks prior to first use of study drug; d) Major surgery or severe trauma within 4 weeks prior to first use of study drug;
- Any active autoimmune disease or history of autoimmune disease including, but not limited to: interstitial pneumonitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies that have been in complete remission and do not require any intervention in adulthood may be considered for inclusion, but patients requiring bronchial Medical intervention with bronchodilators may not be included;
- A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
- Presence of cardiac clinical conditions or diseases that are not well controlled, including, but not limited to, such as (1) NYHA Class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmia that is not clinically intervened with or that remains poorly controlled after clinical intervention;
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 |
|---|---|---|
| SCRT5×5Gy，5Gy/d，QD，D1-D5 | Radiation | SCRT followed by camrelizumab combined with fluzoparib and chemotherapy |
| Camrelizumab200mg, D1, ivgtt, Q3W, C1-4 | Drug | SCRT followed by camrelizumab combined with fluzoparib and chemotherapy |
| Fluzoparib100mg, BID, PO, Q3W, C1-4 | Drug | SCRT followed by camrelizumab combined with fluzoparib and chemotherapy |
| CAPEOXCapecitabine: 1000 mg/m2, BID, PO，D1-14, Q3W, C1-C4； Oxaliplatin: 130mg/m2, D1, ivgtt, 0-2h，Q3W，C1-4 | Drug | SCRT followed by camrelizumab combined with fluzoparib and chemotherapy |
Primary outcome
Adverse events
Time frame: up to 36 months
Incidence and grade according to NCI-CTCAE 5.0(including serious adverse events and immune-related adverse events); Surgical safety: surgical complications, 30 - and 90-day postoperative mortality, length of stay, and reoperation rate
pCR (Pathological Complete Response)
Time frame: up to 6 months
The proportion of subjects with no residual viable tumor cells(ypT0N0) in the primary tumor and lymph nodes, also defined as the proportion of subjects with grade 0 in the AJCC Tumor Regression Grading (TRG) scoring system(version 8.0).
6 secondary outcomes
3-year Event-Free Survival(EFS) rate
Time frame: up to 36 months
Overall Survival(OS)
Time frame: up to 36 months
R0 resection rate
Time frame: up to 6 months
Completion rate of neoadjuvant therapy
Time frame: up to 6 months
Tumor Regression grade (TRG)
Time frame: up to 6 months
quality of life (QOL)
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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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 SCRT, Camrelizumab and Fluzoparib in people with Colorectal Cancer, run by 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 16 inclusion and 11 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 24 Jul 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 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 Xianglin Yuan (13667241722, xlyuan1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: up to 36 months). The study lists 2 primary outcomes in all. 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 24 Jul 2024.