Locally Advanced Rectal CancerPhase 2NCT06304987
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer
A Phase 2 study testing Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor and Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor in people with Locally Advanced Rectal Cancer, run by Beijing Friendship Hospital at 2 sites in China.
Trial summary
This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer. 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?
- Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor and Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2024to May 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
- Sign a written informed consent form and voluntarily join this study;
- Age 18-75 years old, male or female;
- Pathologically confirmed adenocarcinoma of the rectum;
- Clinically staged as II~III stage by MRI (according to the 8th edition of AJCC);
- Tumor lower edge distance from the anal margin ≤10cm;
- Able to undergo surgical resection;
Show all 24Show fewer
- Able to swallow pills normally;
- ECOG PS 0-1;
- No prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.;
- Planning to undergo surgical treatment after completing neoadjuvant therapy;
- No contraindications for surgery;
- Normal major organ function, including:
- Blood routine examination (no blood or blood products transfusion within 14 days before the first treatment, no use of G-CSF or other hematopoietic stimulating factors for correction):
- Neutrophil count ≥1.5×109/L
- Platelet count ≥100×109/L
- Hemoglobin ≥90 g/L
- Blood biochemistry:
- Total bilirubin ≤1.5×ULN
- ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN,
- Serum creatinine ≤1.5×ULN, or creatinine clearance rate ≥50 mL/min (Cocheroft-Gault formula)
- Coagulation function:
- International normalized ratio (INR) ≤ 1.5×ULN
- Activated partial thromboplastin time (APTT) ≤ 1.5×ULN
- Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours before the start of study drug administration, and effective contraception should be used during the trial period and for at least 3 months after the last dose (such as intrauterine devices, contraceptive pills, or condoms); for male subjects with female partners of childbearing potential, effective contraception should be used during the trial period and for 3 months after the last dose.
Who cannot join
- History of allergy to monoclonal antibodies, PD-1 monoclonal antibodies, capecitabine, or oxaliplatin;
- History of receiving or currently receiving any of the following treatments:
- Any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc., for tumors;
- Use of immunosuppressive drugs or systemic steroid therapy to achieve immunosuppression (dose >10mg/day prednisone or equivalent) within 2 weeks before the first use of the study drug; inhalation or local use of steroids and adrenal cortical hormone replacement therapy with a dose >10mg/day prednisone or equivalent is allowed in the absence of active autoimmune diseases;
- Receipt of attenuated live vaccines within 4 weeks before the first use of the study drug;
- Underwent major surgery or had severe trauma within 4 weeks before the first use of the study drug;
Show all 15Show fewer
- Active autoimmune diseases or history of autoimmune diseases, including but not limited to: interstitial pneumonia, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered for inclusion after hormone replacement therapy); psoriasis or childhood asthma/allergies that have completely resolved and do not require any intervention in adulthood may be considered for inclusion, but patients requiring bronchodilators for medical intervention are not eligible for inclusion;
- History of immunodeficiency, including HIV positive, or acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation;
- Presence of poorly controlled clinical symptoms or diseases of the heart, including but not limited to: (1) NYHA class II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or poorly controlled after clinical intervention;
- Severe infection (CTCAE > grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, septicemia, complications of infection, etc.; baseline chest imaging suggests active pulmonary inflammation, presence of symptoms and signs of infection within 14 days before the first use of the study drug or requiring oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics;
- Active pulmonary tuberculosis infection found through medical history or CT examination, or a history of active pulmonary tuberculosis infection within the past year before enrollment, or a history of active pulmonary tuberculosis infection more than 1 year ago but without proper treatment;
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (HCV antibody positive, and HCV RNA higher than the lower limit of detection of the assay);
- Diagnosed with other malignant tumors within 5 years before the first use of the study drug, unless they have a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma in situ of the cervix, may be considered for inclusion;
- Pregnant or lactating women;
- Judged by the investigator to have other factors that may lead to premature termination of the study, such as having other serious diseases (including mental illnesses) requiring concomitant treatment, alcoholism, drug abuse, family or social factors, factors that may affect the safety or compliance of the subject.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
About this study
Official title: The Efficacy and Safety of Preoperative Neoadjuvant Chemoradiation Combined With PD-1 Inhibitor and PCSK9 Inhibitor in the Treatment of pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: a Multicenter Study, Prospective, Randomized Controlled Study
This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer.
Read the detailed description
This study included patients with locally advanced low rectal cancer as research subjects, and evaluated the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor (Sintilimab) and PCSK9 inhibitor (Tafolecimab) or neoadjuvant chemoradiotherapy combined with PD -1 (Sintilimab) for patients with locally advanced rectal cancer. The primary endpoints of the study are clinical complete response (cCR) (including imaging and endoscopic complete response) and pathological complete response (pCR). Secondary endpoints are major pathological response rate (MPR), objective response rate (ORR), disease-free survival (DFS), overall survival (OS), organ preservation rate (OPR), and neoadjuvant rectal (NAR) score, quality of life score (QoL), safety and tolerability.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor, Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor
- Keywords
- pMMR/MSS, PD-1, PCSK9, chemoradiation, neoadjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitorCombination product
In long-course chemoradiotherapy (CRT) + PD-1 inhibitor for LARC patients, the experimental group used concurrent PCSK9 inhibitor, and the active comparison group did not use PCSK9 inhibitor.
Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitorCombination product
In long-course chemoradiotherapy (CRT) + PD-1 inhibitor for LARC patients, the experimental group used concurrent PCSK9 inhibitor, and the active comparison group did not use PCSK9 inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| CRT+PD-1 inhibitor+PCSK9 inhibitor | Experimental | Receive long-course radiotherapy in weeks 1-5: 50 Gy/25 f, 2 Gy/day, days 1-5/week; for 5 consecutive weeks; Simultaneously receive 30 days of capetabine treatment at weeks 1-2, weeks 3-5, and weeks 6-8, 825-1000mg/m2, bid, po, days 1-5/week; PD-1 inhibitor: 200mg, iv.gtt, single dose Infusion, a cycle of 21 days, a total of 3 cycles. Carry out at 2 weeks (days 8-14), 5 weeks (days 29-35), and 8 weeks (days 50-56) after the start of radiotherapy; PCSK9 inhibitor: 600 mg, subcutaneous injection, 1, 7 weeks. Receives: Combination Product: Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor |
| CRT+PD-1 inhibitor | Active comparator | Receive long-course radiotherapy in weeks 1-5: 50 Gy/25 f, 2 Gy/day, days 1-5/week; for 5 consecutive weeks; Simultaneously receive 30 days of capetabine treatment at weeks 1-2, weeks 3-5, and weeks 6-8, 825-1000mg/m2, bid, po, days 1-5/week; PD-1 inhibitor: 200mg, iv.gtt, single dose Infusion, a cycle of 21 days, a total of 3 cycles. Carry out at 2 weeks (days 8-14), 5 weeks (days 29-35), and 8 weeks (days 50-56) after the start of radiotherapy. Receives: Combination Product: Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR
complete response rate=(number of pathological complete responses + number of clinical complete responses)/total number of patients
Measured: pCR :within 10 days after surgery;cCR :12-13 weeks after radiotherapy ends
AE rate
Adverse event rate
Measured: during treatment
Secondary outcomes (4)
NAR score
Neoadjuvant rectal（NAR）score：It is based on the scoring criteria of preoperative treatment
Measured: within 10 days after surgery
OPR
organ preservation rate
Measured: immediately after surgery
ORR
objective response rate
Measured: within 10 days after surgery
immune-related adverse event rate
adverse event rate that is deemed to be associated with PD-1 inhibition
Measured: up to 30th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor Control: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, Changhai Hospital
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304987
- Sponsor's protocol ID
- BFH-niCRT-05
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Export of individual patient data is a sensitive issue according to current Chinese laws.
Publications
Liu X, Bao X, Hu M, Chang H, Jiao M, Cheng J, Xie L, Huang Q, Li F, Li CY. Inhibition of PCSK9 potentiates immune checkpoint therapy for cancer. Nature. 2020 Dec;588(7839):693-698. doi: 10.1038/s41586-020-2911-7. Epub 2020 Nov 11.
PubMed 33177715Cohen J, Pertsemlidis A, Kotowski IK, Graham R, Garcia CK, Hobbs HH. Low LDL cholesterol in individuals of African descent resulting from frequent nonsense mutations in PCSK9. Nat Genet. 2005 Feb;37(2):161-5. doi: 10.1038/ng1509. Epub 2005 Jan 16.
PubMed 15654334Yang Z, Zhang X, Zhang J, Gao J, Bai Z, Deng W, Chen G, An Y, Liu Y, Wei Q, Han J, Li A, Liu G, Sun Y, Kong D, Yao H, Zhang Z. Rationale and design of a prospective, multicenter, phase II clinical trial of safety and efficacy evaluation of long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorectal excision for locally advanced rectal cancer (NCRT-PD1-LARC trial). BMC Cancer. 2022 Apr 27;22(1):462. doi: 10.1186/s12885-022-09554-9.
PubMed 35477432Abifadel M, Varret M, Rabes JP, Allard D, Ouguerram K, Devillers M, Cruaud C, Benjannet S, Wickham L, Erlich D, Derre A, Villeger L, Farnier M, Beucler I, Bruckert E, Chambaz J, Chanu B, Lecerf JM, Luc G, Moulin P, Weissenbach J, Prat A, Krempf M, Junien C, Seidah NG, Boileau C. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet. 2003 Jun;34(2):154-6. doi: 10.1038/ng1161.
PubMed 12730697
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Preoperative Neoadjuvant Chemoradiation Combined With PD-1 Inhibitor and PCSK9 Inhibitor in the Treatment of pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: a Multicenter Study, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06304987
- Acronym / sponsor ID
- BFH-niCRT-05
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- pMMR/MSS, PD-1, PCSK9, chemoradiation, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, Changhai Hospital
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Mar 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.
This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer.
Detailed description
This study included patients with locally advanced low rectal cancer as research subjects, and evaluated the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor (Sintilimab) and PCSK9 inhibitor (Tafolecimab) or neoadjuvant chemoradiotherapy combined with PD -1 (Sintilimab) for patients with locally advanced rectal cancer. The primary endpoints of the study are clinical complete response (cCR) (including imaging and endoscopic complete response) and pathological complete response (pCR). Secondary endpoints are major pathological response rate (MPR), objective response rate (ORR), disease-free survival (DFS), overall survival (OS), organ preservation rate (OPR), and neoadjuvant rectal (NAR) score, quality of life score (QoL), safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor Control: Neoadjuvant chemoradiotherapy combined with PD-1 inhibitor
| Arm | Type | Receives |
|---|---|---|
| CRT+PD-1 inhibitor+PCSK9 inhibitor | Experimental | Combination Product: Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitorReceive long-course radiotherapy in weeks 1-5: 50 Gy/25 f, 2 Gy/day, days 1-5/week; for 5 consecutive weeks; Simultaneously receive 30 days of capetabine treatment at weeks 1-2, weeks 3-5, and weeks 6-8, 825-1000mg/m2, bid, po, days 1-5/week; PD-1 inhibitor: 200mg, iv.gtt, single dose Infusion, a cycle of 21 days, a total of 3 cycles. Carry out at 2 weeks (days 8-14), 5 weeks (days 29-35), and 8 weeks (days 50-56) after the start of radiotherapy; PCSK9 inhibitor: 600 mg, subcutaneous injection, 1, 7 weeks. |
| CRT+PD-1 inhibitor | Active comparator | Combination Product: Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitorReceive long-course radiotherapy in weeks 1-5: 50 Gy/25 f, 2 Gy/day, days 1-5/week; for 5 consecutive weeks; Simultaneously receive 30 days of capetabine treatment at weeks 1-2, weeks 3-5, and weeks 6-8, 825-1000mg/m2, bid, po, days 1-5/week; PD-1 inhibitor: 200mg, iv.gtt, single dose Infusion, a cycle of 21 days, a total of 3 cycles. Carry out at 2 weeks (days 8-14), 5 weeks (days 29-35), and 8 weeks (days 50-56) after the start of radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Sign a written informed consent form and voluntarily join this study;
- Age 18-75 years old, male or female;
- Pathologically confirmed adenocarcinoma of the rectum;
- Clinically staged as II~III stage by MRI (according to the 8th edition of AJCC);
- Tumor lower edge distance from the anal margin ≤10cm;
Key exclusion criteria (15 listed)
- History of allergy to monoclonal antibodies, PD-1 monoclonal antibodies, capecitabine, or oxaliplatin;
- History of receiving or currently receiving any of the following treatments:
- Active autoimmune diseases or history of autoimmune diseases, including but not limited to: interstitial pneumonia, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered for inclusion after hormone replacement therapy); psoriasis or childhood asthma/allergies that have completely resolved and do not require any intervention in adulthood may be considered for inclusion, but patients requiring bronchodilators for medical intervention are not eligible for inclusion;
- History of immunodeficiency, including HIV positive, or acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation;
- Presence of poorly controlled clinical symptoms or diseases of the heart, including but not limited to: (1) NYHA class II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or 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 |
|---|---|---|
| Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitorIn long-course chemoradiotherapy (CRT) + PD-1 inhibitor for LARC patients, the experimental group used concurrent PCSK9 inhibitor, and the active comparison group did not use PCSK9 inhibitor. | Combination product | CRT+PD-1 inhibitor |
| Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitorIn long-course chemoradiotherapy (CRT) + PD-1 inhibitor for LARC patients, the experimental group used concurrent PCSK9 inhibitor, and the active comparison group did not use PCSK9 inhibitor. | Combination product | CRT+PD-1 inhibitor+PCSK9 inhibitor |
Primary outcome
CR
Time frame: pCR :within 10 days after surgery;cCR :12-13 weeks after radiotherapy ends
complete response rate=(number of pathological complete responses + number of clinical complete responses)/total number of patients
AE rate
Time frame: during treatment
Adverse event rate
4 secondary outcomes
NAR score
Time frame: within 10 days after surgery
OPR
Time frame: immediately after surgery
ORR
Time frame: within 10 days after surgery
immune-related adverse event rate
Time frame: up to 30th day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 33177715Liu X, Bao X, Hu M, Chang H, Jiao M, Cheng J, Xie L, Huang Q, Li F, Li CY. Inhibition of PCSK9 potentiates immune checkpoint therapy for cancer. Nature. 2020 Dec;588(7839):693-698. doi: 10.1038/s41586-020-2911-7. Epub 2020 Nov 11.
- Background: PubMed 15654334Cohen J, Pertsemlidis A, Kotowski IK, Graham R, Garcia CK, Hobbs HH. Low LDL cholesterol in individuals of African descent resulting from frequent nonsense mutations in PCSK9. Nat Genet. 2005 Feb;37(2):161-5. doi: 10.1038/ng1509. Epub 2005 Jan 16.
- Background: PubMed 35477432Yang Z, Zhang X, Zhang J, Gao J, Bai Z, Deng W, Chen G, An Y, Liu Y, Wei Q, Han J, Li A, Liu G, Sun Y, Kong D, Yao H, Zhang Z. Rationale and design of a prospective, multicenter, phase II clinical trial of safety and efficacy evaluation of long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorectal excision for locally advanced rectal cancer (NCRT-PD1-LARC trial). BMC Cancer. 2022 Apr 27;22(1):462. doi: 10.1186/s12885-022-09554-9.
- Background: PubMed 12730697Abifadel M, Varret M, Rabes JP, Allard D, Ouguerram K, Devillers M, Cruaud C, Benjannet S, Wickham L, Erlich D, Derre A, Villeger L, Farnier M, Beucler I, Bruckert E, Chambaz J, Chanu B, Lecerf JM, Luc G, Moulin P, Weissenbach J, Prat A, Krempf M, Junien C, Seidah NG, Boileau C. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet. 2003 Jun;34(2):154-6. doi: 10.1038/ng1161.
- Individual participant dataSharing planned: No. Export of individual patient data is a sensitive issue according to current Chinese laws.
Related trials for Locally Advanced Rectal Cancer
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
Not yet recruitingPhase 3
Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer
Locally Advanced Rectal 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor and Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor in people with Locally Advanced Rectal Cancer, run by Beijing Friendship Hospital at 2 sites 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 24 inclusion and 15 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Zhongtao Zhang, MD (+86 13801060364, Zhangzht@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR (time frame: pCR :within 10 days after surgery;cCR :12-13 weeks after radiotherapy ends). 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?
On the ClinicalTrials.gov record for NCT06304987, which also lists 4 linked publications.
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 19 Mar 2024.