Rectal Squamous Cell CarcinomaPhase 2NCT06364384
Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma
A Phase 2 study testing PD-1 and CRT in people with Rectal Squamous Cell Carcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Squamous Cell Carcinoma
- What is being tested?
- PD-1 and CRT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2024to 8 Jun 2029
- Phase
- Phase 2
- 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
- Voluntarily sign the informed consent;
- 18-75 years old;
- Patients with pathologically confirmed rectal squamous cell carcinoma;
- imaging to rule out distant metastases;
- Peripheral blood and liver and kidney function before treatment within the following allowable limits (tested within 14 days before the start of treatment)
- White blood cell (WBC) ≥ 3.0×109/L or neutrophil (ANC) ≥1.5×109/L;
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- Hemoglobin (HGB) ≥80 g/L;
- Platelets (PLT) ≥ 100×109/L;
- Hepatic transaminases (AST/ALT) < 3.0 times the upper limit of the normal range;
- Total bilirubin (TBIL) < 1.5 times the upper limit of the normal range;
- Creatinine (CREAT) < 1.5 times the upper limit of the normal range.
- ECOG performance status score of 0-2;
- No history of other malignant tumors in the past.
Who cannot join
- Non-treatment-naïve patients who have previously received chemotherapy, radiotherapy or complete surgical resection of rectal squamous cell carcinoma;
- Distant metastases (M1) confirmed by whole-body CT, MR, or PET-CT (including at least the chest, abdomen, and pelvis);
- Previous or concurrent presence of other active malignancies (except for malignant tumors that have received curative therapy and have been disease-free for more than 3 years or carcinoma in situ that can be cured by adequate treatment);
- Major surgery such as laparotomy, thoracotomy, resection of organs by laparoscopic surgery or severe trauma within the past 4 weeks (the surgical incision should be completely healed before randomization);
- Active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to enrollment in the study;
- Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis within the past 6 months;
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- New York Heart Association (NYHA) Class II or above congestive heart failure;
- Prior receipt of any investigational drug;
- Pregnant or lactating women;
- Any medical condition that is unstable or would affect patient safety and their compliance with the study;
- Patients judged by the investigator to be unsuitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Jun Huang, MD, +86-13926451242, huangj97@mail.sysu.edu.cn
About this study
Official title: Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Newly Diagnosed Non-metastatic Rectal Squamous Cell Carcinoma: A Multicenter, Prospective, Single Arm, Phase II Study(RICH).
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are:
Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime？ Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs.
Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY.
Read the detailed description
Rectal squamous cell cancer (rSCC) is a rare malignancy, and its incidence is increasing year by year. Due to the rarity of rSCC, there is no consensus on its epidemiology, pathogenesis, prognosis and treatment management. Due to the limitation of clinical data, there is an urgent need for further clinical exploration and research.
In recent years, the combination of CRT and immunotherapy has attracted more and more attention, as they may have more advantages over CRT alone.A number of prospective clinical trials of PD-1 monoclonal antibody combined with CRT for the first-line treatment of advanced aSCC are also underway (NCT03233711, NCT04230759, NCT05661188, NCT05374252, etc.). Similarly, the efficacy and safety of PD-1 monoclonal antibody in rSCC patients are also worthy of further discussion, in order to further improve the survival prognosis of rSCC patients. Our previous study data showed that the 3-year OS and DFS of radical CRT were 88.9% and 66.7%, respectively, for non-metastatic rSCC, and 100% and DFS for radical CRT combined with immunotherapy, respectively, and CRT combined with immunotherapy significantly improved survival compared with radical CRT (P=0.02).
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. Therefore, we plan to conduct a multicenter, prospective, single-arm, phase II study to provide evidence-based medical evidence for the treatment of locally advanced rectal squamous cell carcinoma.
The primary outcome is 1-year tumor-free survival (DFS), and the secondary outcomes are including 1-year overall survival (OS), 1-year relapse-free survival (RFS), 1-year metastasis free survival (DMFS), 1-year stoma-free survival, incidence of chemotherapy and immunotherapy-related adverse reactions and complete response rate (CRR).
Participants will receive interventions below:
Chemotherapy (/4W): a)DDP 75 mg/m2, d1, intravenous infusion; b)5-FU 1000 mg/m2, d1-4, continuous pumping intravenously; Immunotherapy (/4W): PD-1 monoclonal antibody(sintlimab) 200mg, d1, intravenous infusion; Radiotherapy (at 2rd week after firstime of chemotherapy):Daily single dose of 2Gy, with a total dose of 50-54Gy(clinical I-II stage)/54-59Gy(clinical III stage).
- Conditions
- Rectal Squamous Cell Carcinoma
- Being tested
- PD-1 and CRT
- Keywords
- PD-1, Chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 and CRTCombination product
Chemotherapy (/4W): a)DDP 75 mg/m2, d1, intravenous infusion; b)5-FU 1000 mg/m2, d1-4, continuous pumping intravenously; Immunotherapy (/4W): PD-1 monoclonal antibody(sintlimab) 200mg, d1, intravenous infusion; Radiotherapy (at 2rd week after firstime of chemotherapy):Daily single dose of 2Gy, with a total dose of 50-54Gy(clinical I-II stage)/54-59Gy(clinical III stage).
| Study group | Role | What they receive |
|---|---|---|
| PD-1 + CRT | Experimental | Patients from experimental group are underwent treatment together with PD-1 monoclonal antibody and radical CRT Receives: Combination Product: PD-1 and CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year tumor-free survival(DFS)
The proportion of patients who do not have any of the following events from the beginning of randomization to the end of the first year
Measured: 3 year
Secondary outcomes (6)
1-year overall survival (OS)
Time interval from the date of randomization to death
Measured: 1 year
1-year relapse-free survival (RFS)
Time interval from the date of randomization to the onset of recurrence
Measured: 1 year
1-year metastasis free survival (DMFS)
Time interval from the date of randomization to the occurrence of distant metastases
Measured: 1 year
Incidence of chemotherapy and immunotherapy-related adverse reactions
The occurrence of chemotherapy and immune-related side effects during treatment
Measured: through study completion, an average of 6 months
Complete response rate (CRR)
The proportion of the total number of patients with complete response after treatment to the total number of evaluable cases in solid tumor treatment studies
Measured: through study completion, an average of 6 months
1-year stoma-free survival
The occurrence of stoma
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 posted15 Apr 2024
- Study start12 Apr 2024
- Primary completion8 Sep 2026 (estimated)
- Study completion8 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Huang, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364384
- Sponsor's protocol ID
- E2024074
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Newly Diagnosed Non-metastatic Rectal Squamous Cell Carcinoma: A Multicenter, Prospective, Single Arm, Phase II Study(RICH).
- ClinicalTrials.gov ID
- NCT06364384
- Acronym / sponsor ID
- E2024074
- Conditions
- Rectal Squamous Cell Carcinoma
- Keywords
- PD-1, Chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 8 Sep 2026 (estimated)
- Study completion
- 8 Jun 2029 (estimated)
- First posted
- 15 Apr 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.
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are:
Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime？ Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs.
Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY.
Detailed description
Rectal squamous cell cancer (rSCC) is a rare malignancy, and its incidence is increasing year by year. Due to the rarity of rSCC, there is no consensus on its epidemiology, pathogenesis, prognosis and treatment management. Due to the limitation of clinical data, there is an urgent need for further clinical exploration and research.
In recent years, the combination of CRT and immunotherapy has attracted more and more attention, as they may have more advantages over CRT alone.A number of prospective clinical trials of PD-1 monoclonal antibody combined with CRT for the first-line treatment of advanced aSCC are also underway (NCT03233711, NCT04230759, NCT05661188, NCT05374252, etc.). Similarly, the efficacy and safety of PD-1 monoclonal antibody in rSCC patients are also worthy of further discussion, in order to further improve the survival prognosis of rSCC patients. Our previous study data showed that the 3-year OS and DFS of radical CRT were 88.9% and 66.7%, respectively, for non-metastatic rSCC, and 100% and DFS for radical CRT combined with immunotherapy, respectively, and CRT combined with immunotherapy significantly improved survival compared with radical CRT (P=0.02).
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. Therefore, we plan to conduct a multicenter, prospective, single-arm, phase II study to provide evidence-based medical evidence for the treatment of locally advanced rectal squamous cell carcinoma.
The primary outcome is 1-year tumor-free survival (DFS), and the secondary outcomes are including 1-year overall survival (OS), 1-year relapse-free survival (RFS), 1-year metastasis free survival (DMFS), 1-year stoma-free survival, incidence of chemotherapy and immunotherapy-related adverse reactions and complete response rate (CRR).
Participants will receive interventions below:
Chemotherapy (/4W): a)DDP 75 mg/m2, d1, intravenous infusion; b)5-FU 1000 mg/m2, d1-4, continuous pumping intravenously; Immunotherapy (/4W): PD-1 monoclonal antibody(sintlimab) 200mg, d1, intravenous infusion; Radiotherapy (at 2rd week after firstime of chemotherapy):Daily single dose of 2Gy, with a total dose of 50-54Gy(clinical I-II stage)/54-59Gy(clinical III stage).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 + CRT | Experimental | Combination Product: PD-1 and CRTPatients from experimental group are underwent treatment together with PD-1 monoclonal antibody and radical CRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily sign the informed consent;
- 18-75 years old;
- Patients with pathologically confirmed rectal squamous cell carcinoma;
- imaging to rule out distant metastases;
- Peripheral blood and liver and kidney function before treatment within the following allowable limits (tested within 14 days before the start of treatment)
Key exclusion criteria (11 listed)
- Non-treatment-naïve patients who have previously received chemotherapy, radiotherapy or complete surgical resection of rectal squamous cell carcinoma;
- Distant metastases (M1) confirmed by whole-body CT, MR, or PET-CT (including at least the chest, abdomen, and pelvis);
- Previous or concurrent presence of other active malignancies (except for malignant tumors that have received curative therapy and have been disease-free for more than 3 years or carcinoma in situ that can be cured by adequate treatment);
- Major surgery such as laparotomy, thoracotomy, resection of organs by laparoscopic surgery or severe trauma within the past 4 weeks (the surgical incision should be completely healed before randomization);
- Active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to 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 |
|---|---|---|
| PD-1 and CRTChemotherapy (/4W): a)DDP 75 mg/m2, d1, intravenous infusion; b)5-FU 1000 mg/m2, d1-4, continuous pumping intravenously; Immunotherapy (/4W): PD-1 monoclonal antibody(sintlimab) 200mg, d1, intravenous infusion; Radiotherapy (at 2rd week after firstime of chemotherapy):Daily single dose of 2Gy, with a total dose of 50-54Gy(clinical I-II stage)/54-59Gy(clinical III stage). | Combination product | PD-1 + CRT |
Primary outcome
3-year tumor-free survival(DFS)
Time frame: 3 year
The proportion of patients who do not have any of the following events from the beginning of randomization to the end of the first year
6 secondary outcomes
1-year overall survival (OS)
Time frame: 1 year
1-year relapse-free survival (RFS)
Time frame: 1 year
1-year metastasis free survival (DMFS)
Time frame: 1 year
Incidence of chemotherapy and immunotherapy-related adverse reactions
Time frame: through study completion, an average of 6 months
Complete response rate (CRR)
Time frame: through study completion, an average of 6 months
1-year stoma-free survival
Time frame: 1 year
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 1 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.
Jun Huang, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen 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 and CRT in people with Rectal Squamous Cell Carcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen 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 13 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: looking for participants now, as of the sponsor's last update on 1 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 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?
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 Jun Huang, MD (+86-13926451242, huangj97@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year tumor-free survival(DFS) (time frame: 3 year). 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 1 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.