Local Advanced Rectal CancerPhase 3NCT07686796
Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial
A Phase 3 study testing Short-course radiotherapy, CAPOX (oxaliplatin/capecitabine) and Sintilimab in people with Local Advanced Rectal Cancer and PD-1 Inhibitor, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This is a randomized, controlled clinical trial based on prior exploratory findings, designed to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tafolecimab(an anti-PCSK9 inhibitor) and sintilimab (an anti-PD-1 inhibitor) versus neoadjuvant chemoradiotherapy combined with sintilimab… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Local Advanced Rectal Cancer, PD-1 Inhibitor, PCSK9 Inhibitor
- What is being tested?
- Short-course radiotherapy, CAPOX (oxaliplatin/capecitabine) and Sintilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 1 Jan 2035
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age 18 to 75 years, any sex.
- Histologically confirmed rectal adenocarcinoma, determined to be pMMR (proficient mismatch repair) or MSS (microsatellite stable) by immunohistochemistry and/or genetic testing; clinical stage cT3/T4 or cN+; distal tumor margin ≤ 12 cm from the anal verge; and eligible for surgical resection.
- No evidence of distant metastases.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate hematologic and biochemical function: absolute neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 10⁹/L, ALT/AST ≤ 2.5 times the upper limit of normal (ULN), creatinine ≤ 3.0 × ULN.
- Anticipated good compliance and provision of written informed consent.
Who cannot join
- Known allergy or severe adverse reaction to any study drug, including tafolecimab, PD-1 inhibitor (sintilimab), capecitabine, oxaliplatin, or any excipients.
- Rectal cancer confirmed as dMMR (deficient mismatch repair) or MSI-H (microsatellite instability-high).
- Pregnant or breastfeeding women, or patients of childbearing potential who refuse to use effective contraception during the study.
- Other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, papillary thyroid carcinoma, or other malignancies considered cured after adequate treatment.
- Prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, or local surgical excision.
- Previous treatment with a PCSK9 inhibitor for any indication.
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- Severe or uncontrolled neurological disease, psychiatric disorder, or cognitive impairment that, in the investigator's judgment, would affect informed consent or protocol adherence.
- Severe cardiovascular or cerebrovascular disease, including but not limited to: unstable angina, myocardial infarction, coronary revascularization, or stroke within 6 months before enrollment; clinically significant arrhythmia requiring treatment or left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) class III or IV heart failure.
- Active infection requiring long-term systemic therapy (e.g., antibiotics, antivirals, or antifungals).
- Active autoimmune disease, or requirement for long-term systemic immunosuppressive therapy or corticosteroids (at a dose equivalent to prednisone > 10 mg/day).
- Known history of human immunodeficiency virus (HIV) infection, or active syphilis, or active pulmonary tuberculosis.
- Active hepatitis B (HBsAg positive and HBV DNA > 200 IU/mL or > 1000 copies/mL) or active hepatitis C (HCV RNA positive).
- Any other clinical condition that, in the investigator's opinion, could interfere with study assessments, increase treatment risk, or lead to premature study discontinuation (including but not limited to severe alcohol or drug abuse).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a randomized, controlled clinical trial based on prior exploratory findings, designed to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tafolecimab(an anti-PCSK9 inhibitor) and sintilimab (an anti-PD-1 inhibitor) versus neoadjuvant chemoradiotherapy combined with sintilimab alone in patients with pMMR/MSS locally advanced rectal cancer. The primary endpoint is the complete response (CR) rate, including the pathological complete response (pCR) rate in patients who undergo surgery after neoadjuvant therapy, and the clinical complete response (cCR) rate in patients managed with a watch-and-wait strategy. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), downstaging rate, R0 resection rate, tumor regression grade, sphincter preservation rate, disease-free survival (DFS), overall survival (OS), and safety.
- Conditions
- Local Advanced Rectal Cancer, PD-1 Inhibitor, PCSK9 Inhibitor, RCT, Radiotherapy, Capecitabine
- Being tested
- Short-course radiotherapy, CAPOX (oxaliplatin/capecitabine), Sintilimab, Tafolecimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-course radiotherapyRadiation
Total dose: 25 Gy, to be completed in 5 sessions (once a day for 5 days). After the short-course radiotherapy, a 1-week rest is required before moving on to the next stage of treatment.
CAPOX (oxaliplatin/capecitabine)Drug
One week after short-course radiotherapy, 6 cycles of CAPOX chemotherapy combined with PD-1 inhibitor immunotherapy were administered. Each cycle lasted for 3 weeks, for a total of 6 cycles.
(One cycle is defined as: Oxaliplatin, 130 mg/m², intravenous infusion, on day 1. Capecitabine, 1000 mg/m², orally, twice a day (morning and evening), from day 1 to day 14.)
SintilimabDrug
For patients with a body weight of less than 60 kg, the dose is 3 mg/kg, administered by intravenous infusion on the first day; for patients with a body weight of 60 kg or more, the dose is 200 mg, also administered by intravenous infusion on the first day.
TafolecimabDrug
The entire course of treatment with PCSK9 inhibitor (Tafolecimab) was administered, with 450 mg of Tafolecimab administered subcutaneously. (The treatment involved neoadjuvant radiotherapy and chemotherapy combined with immunotherapy and Tafolecimab. The treatment was carried out from the time the patient began receiving short-course radiotherapy. Each cycle consisted of 4 weeks, with injection on the first day of each cycle, for a total of 6 times.)
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemoradiotherapy plus Sintilimab and Tafolecimab | Experimental | Short-course radiotherapy (SCRT): total dose 25 Gy in 5 daily fractions, followed by a 1-week rest. One week after SCRT, 6 cycles of CAPOX chemotherapy plus sintilimab are given (each cycle = 21 days). CAPOX consists of oxaliplatin 130 mg/m² IV on Day 1 and capecitabine 1000 mg/m² orally twice daily on Days 1-14. Sintilimab is administered at 3 mg/kg IV (body weight <60 kg) or 200 mg IV (body weight ≥60 kg) on Day 1 of each cycle. Throughout the neoadjuvant period, tafolecimab 450 mg is administered subcutaneously once every 4 weeks for 6 doses, starting on the first day of SCRT. Receives: Radiation: Short-course radiotherapy; Drug: CAPOX (oxaliplatin/capecitabine); Drug: Sintilimab; Drug: Tafolecimab |
| Neoadjuvant Chemoradiotherapy plus Sintilimab | Active comparator | Short-course radiotherapy (SCRT): total dose 25 Gy in 5 daily fractions, followed by a 1-week rest. One week after SCRT, 6 cycles of CAPOX chemotherapy plus sintilimab are given (each cycle = 21 days). CAPOX consists of oxaliplatin 130 mg/m² IV on Day 1 and capecitabine 1000 mg/m² orally twice daily on Days 1-14. Sintilimab is administered at 3 mg/kg IV (body weight <60 kg) or 200 mg IV (body weight ≥60 kg) on Day 1 of each cycle. Receives: Radiation: Short-course radiotherapy; Drug: CAPOX (oxaliplatin/capecitabine); Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
Defined as the Proportion of Participants Achieving Pathological Complete Response (pCR) After Surgery or Clinical Complete Response (cCR) Under Watch-and-Wait Strategy Following Neoadjuvant Therapy
Measured: Within 4 weeks after completion of neoadjuvant therapy for cCR and within 2 weeks after the time of surgery for pCR
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: From the first dose of neoadjuvant treatment
Secondary outcomes (7)
Major Pathological Response (MPR) Rate
Measured: within 2 weeks after the time of surgery
Objective Response Rate (ORR)
Measured: Within 4 weeks after completion of neoadjuvant therapy or within 2 weeks after surgery;
Downstaging Rate
Measured: Within 4 weeks after completion of neoadjuvant therapy or within 2 weeks after surgery;
Tumor Regression Grade (TRG)
Measured: Within 2 weeks after surgery;
R0 Resection Rate
Measured: Within 2 weeks after surgery;
Disease-Free Survival (DFS)
Measured: approximately 5 years after completion of neoadjuvant chemotherapy
Overall Survival (OS)
Measured: approximately 5 years after completion of neoadjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, Sixth Affiliated Hospital, Sun Yat-sen University, Sun Yat-Sen University Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Affiliated Hospital of Qinghai University, Zhangzhou Hospital, Fujian Province, The First Affiliated Hospital of Xiamen University, Ruijin Hospital, The First Hospital of Jilin University, Peking University Cancer Hospital & Institute, Second Affiliated Hospital of Nanchang University, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Third Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Meizhou People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686796
- Sponsor's protocol ID
- PIONEER-02
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2026
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial
- ClinicalTrials.gov ID
- NCT07686796
- Acronym / sponsor ID
- PIONEER-02
- Conditions
- Local Advanced Rectal Cancer, PD-1 Inhibitor, PCSK9 Inhibitor, RCT, Radiotherapy, Capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, Sixth Affiliated Hospital, Sun Yat-sen University, Sun Yat-Sen University Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Affiliated Hospital of Qinghai University, Zhangzhou Hospital, Fujian Province, The First Affiliated Hospital of Xiamen University, Ruijin Hospital, The First Hospital of Jilin University, Peking University Cancer Hospital & Institute, Second Affiliated Hospital of Nanchang University, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Third Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Meizhou People's Hospital
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 7 Jul 2026 (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 randomized, controlled clinical trial based on prior exploratory findings, designed to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tafolecimab(an anti-PCSK9 inhibitor) and sintilimab (an anti-PD-1 inhibitor) versus neoadjuvant chemoradiotherapy combined with sintilimab alone in patients with pMMR/MSS locally advanced rectal cancer. The primary endpoint is the complete response (CR) rate, including the pathological complete response (pCR) rate in patients who undergo surgery after neoadjuvant therapy, and the clinical complete response (cCR) rate in patients managed with a watch-and-wait strategy. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), downstaging rate, R0 resection rate, tumor regression grade, sphincter preservation rate, disease-free survival (DFS), overall survival (OS), and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemoradiotherapy plus Sintilimab and Tafolecimab | Experimental | Radiation: Short-course radiotherapy, Drug: CAPOX (oxaliplatin/capecitabine), Drug: Sintilimab, Drug: TafolecimabShort-course radiotherapy (SCRT): total dose 25 Gy in 5 daily fractions, followed by a 1-week rest. One week after SCRT, 6 cycles of CAPOX chemotherapy plus sintilimab are given (each cycle = 21 days). CAPOX consists of oxaliplatin 130 mg/m² IV on Day 1 and capecitabine 1000 mg/m² orally twice daily on Days 1-14. Sintilimab is administered at 3 mg/kg IV (body weight <60 kg) or 200 mg IV (body weight ≥60 kg) on Day 1 of each cycle. Throughout the neoadjuvant period, tafolecimab 450 mg is administered subcutaneously once every 4 weeks for 6 doses, starting on the first day of SCRT. |
| Neoadjuvant Chemoradiotherapy plus Sintilimab | Active comparator | Radiation: Short-course radiotherapy, Drug: CAPOX (oxaliplatin/capecitabine), Drug: SintilimabShort-course radiotherapy (SCRT): total dose 25 Gy in 5 daily fractions, followed by a 1-week rest. One week after SCRT, 6 cycles of CAPOX chemotherapy plus sintilimab are given (each cycle = 21 days). CAPOX consists of oxaliplatin 130 mg/m² IV on Day 1 and capecitabine 1000 mg/m² orally twice daily on Days 1-14. Sintilimab is administered at 3 mg/kg IV (body weight <60 kg) or 200 mg IV (body weight ≥60 kg) on Day 1 of each cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 75 years, any sex.
- Histologically confirmed rectal adenocarcinoma, determined to be pMMR (proficient mismatch repair) or MSS (microsatellite stable) by immunohistochemistry and/or genetic testing; clinical stage cT3/T4 or cN+; distal tumor margin ≤ 12 cm from the anal verge; and eligible for surgical resection.
- No evidence of distant metastases.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate hematologic and biochemical function: absolute neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 10⁹/L, ALT/AST ≤ 2.5 times the upper limit of normal (ULN), creatinine ≤ 3.0 × ULN.
Key exclusion criteria (13 listed)
- Known allergy or severe adverse reaction to any study drug, including tafolecimab, PD-1 inhibitor (sintilimab), capecitabine, oxaliplatin, or any excipients.
- Rectal cancer confirmed as dMMR (deficient mismatch repair) or MSI-H (microsatellite instability-high).
- Pregnant or breastfeeding women, or patients of childbearing potential who refuse to use effective contraception during the study.
- Other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, papillary thyroid carcinoma, or other malignancies considered cured after adequate treatment.
- Prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, or local surgical excision.
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 |
|---|---|---|
| Short-course radiotherapyTotal dose: 25 Gy, to be completed in 5 sessions (once a day for 5 days). After the short-course radiotherapy, a 1-week rest is required before moving on to the next stage of treatment. | Radiation | Neoadjuvant Chemoradiotherapy plus Sintilimab, Neoadjuvant Chemoradiotherapy plus Sintilimab and Tafolecimab |
| CAPOX (oxaliplatin/capecitabine)One week after short-course radiotherapy, 6 cycles of CAPOX chemotherapy combined with PD-1 inhibitor immunotherapy were administered. Each cycle lasted for 3 weeks, for a total of 6 cycles. (One cycle is defined as: Oxaliplatin, 130 mg/m², intravenous infusion, on day 1. Capecitabine, 1000 mg/m², orally, twice a day (morning and evening), from day 1 to day 14.) | Drug | Neoadjuvant Chemoradiotherapy plus Sintilimab, Neoadjuvant Chemoradiotherapy plus Sintilimab and Tafolecimab |
| SintilimabFor patients with a body weight of less than 60 kg, the dose is 3 mg/kg, administered by intravenous infusion on the first day; for patients with a body weight of 60 kg or more, the dose is 200 mg, also administered by intravenous infusion on the first day. | Drug | Neoadjuvant Chemoradiotherapy plus Sintilimab, Neoadjuvant Chemoradiotherapy plus Sintilimab and Tafolecimab |
| TafolecimabThe entire course of treatment with PCSK9 inhibitor (Tafolecimab) was administered, with 450 mg of Tafolecimab administered subcutaneously. (The treatment involved neoadjuvant radiotherapy and chemotherapy combined with immunotherapy and Tafolecimab. The treatment was carried out from the time the patient began receiving short-course radiotherapy. Each cycle consisted of 4 weeks, with injection on the first day of each cycle, for a total of 6 times.) | Drug | Neoadjuvant Chemoradiotherapy plus Sintilimab and Tafolecimab |
Primary outcome
Complete Response (CR) Rate
Time frame: Within 4 weeks after completion of neoadjuvant therapy for cCR and within 2 weeks after the time of surgery for pCR
Defined as the Proportion of Participants Achieving Pathological Complete Response (pCR) After Surgery or Clinical Complete Response (cCR) Under Watch-and-Wait Strategy Following Neoadjuvant Therapy
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From the first dose of neoadjuvant treatment
7 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: within 2 weeks after the time of surgery
Objective Response Rate (ORR)
Time frame: Within 4 weeks after completion of neoadjuvant therapy or within 2 weeks after surgery;
Downstaging Rate
Time frame: Within 4 weeks after completion of neoadjuvant therapy or within 2 weeks after surgery;
Tumor Regression Grade (TRG)
Time frame: Within 2 weeks after surgery;
R0 Resection Rate
Time frame: Within 2 weeks after surgery;
Disease-Free Survival (DFS)
Time frame: approximately 5 years after completion of neoadjuvant chemotherapy
Overall Survival (OS)
Time frame: approximately 5 years after completion of neoadjuvant chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Short-course radiotherapy, CAPOX (oxaliplatin/capecitabine) and Sintilimab in people with Local Advanced Rectal Cancer and PD-1 Inhibitor, run by Guangdong Provincial People's 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 6 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: opening soon, as of the sponsor's last update on 7 Jul 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Li (13822177479, liyong@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate (time frame: Within 4 weeks after completion of neoadjuvant therapy for cCR and within 2 weeks after the time of surgery for pCR). 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 7 Jul 2026.