Anal Squamous Cell Carcinoma, Limited-stagePhase 3NCT07692152
Sintilimab Versus Mitomycin in Combination With Capecitabine and IMRT for Limited-stage Anal Squamous Cell Carcinoma
A Phase 3 study testing Intensity-Modulated Radiotherapy (IMRT), Capecitabine and Sintilimab in people with Anal Squamous Cell Carcinoma, Limited-stage, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.
Trial summary
This is a prospective, multicenter, open-label, phase III randomized controlled clinical trial designed to evaluate the efficacy and safety of replacing the traditional chemotherapeutic drug mitomycin with the PD-1 inhibitor sintilimab in definitive chemoradiotherapy for limited-stage anal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anal Squamous Cell Carcinoma, Limited-stage
- What is being tested?
- Intensity-Modulated Radiotherapy (IMRT), 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
- 350 participants
- Where
- 2 sitesChina
- Study dates
- 17 Mar 2026to Mar 2029
- 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
- Histopathologically confirmed primary anal squamous cell carcinoma, including a subset of rectal squamous cell carcinomas. Definition for inclusion of rectal squamous cell carcinomas: According to Williams' criteria (1979) and WHO classification (2019), rectal squamous cell carcinomas included in this study must meet all of the following criteria: (1) Histopathologically confirmed as pure squamous cell carcinoma, excluding adenosquamous carcinoma; (2) Digital examination/endoscopy/MRI confirmation that the tumor mass is entirely located in the rectum (above the dentate line), with no evidence of primary origin in the anal canal or upward spread. If the inferior border of the tumor is within 5-6 cm from the anal verge, and the patient is scheduled to undergo radical radiotherapy and chemotherapy, the rectal squamous cell carcinoma can be diagnosed and screened for inclusion (When the primary epicenter cannot be determined, regardless of which side the tumor mass is biased towards, the diagnosis shall be considered for screening and inclusion as anal squamous cell carcinoma); (3) Female patients must be excluded for rectal metastasis from cervical squamous cell carcinoma (baseline gynecological examination is recommended).
- Staged as cT2-T4N0M0 or cTanyN+M0 by imaging (AJCC 9th).
- No prior tumor resection surgery (other than biopsy) or chemotherapy or other anti-tumor therapy.
- Aged 18-75 years old.
- ECOG performance status of 0-1.
- Adequate organ function reserve: white blood cell (WBC) count ≥3 × 10^9/L, absolute neutrophil count (ANC) ≥1.5 × 10^9/L, hemoglobin (Hb) level >90 g/L, platelet (PLT) count >100 × 10^9/L; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <2.5 times the upper limit of normal (ULN); serum bilirubin level ≤1.5 × ULN; serum creatinine (Cr) level <1.5 × ULN; international normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5 × ULN.
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- No known history of allergy to the study drugs.
- No prior radiotherapy to the planned radiation site.
- Non-pregnant and non-lactating women.
- For HIV-positive patients: at the initiation of the study, a stable combined antiretroviral therapy (CART) regimen must be used, with an HIV viral load of <50 copies/mL or below the limit of detection, and a CD4+ T-cell count >300/µL. Patients will be closely monitored during the study, and CART management will follow antiviral treatment guideline recommendations.
- Signed informed consent form.
Who cannot join
- Perianal squamous cell carcinoma originating from the perianal skin without invasion of the anal canal or anal sphincter. (For tumors with an ill-defined primary site, if clinical judgment indicates the main tumor mass involves the anal canal or is associated with anal sphincter invasion requiring sphincter-preserving chemoradiotherapy, the patient is eligible for inclusion.)
- Perianal Paget's disease.
- Pregnant or lactating women.
- Severe comorbidities or any medical/psychiatric condition deemed unsuitable for participation in this study.
- Patients with prior antitumor immunotherapy (e.g., anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies, etc.), with the exception of anti-HPV vaccination.
- History of other malignancies diagnosed within the past 3 years, except for curatively treated basal cell carcinoma of the skin and/or completely resected carcinoma in situ of the cervix, breast, or thyroid.
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- Requires chronic use of immunosuppressive medications.
- Patients with severe autoimmune diseases, including but not limited to: symptomatic interstitial lung disease, or active infectious/non-infectious pneumonia; active inflammatory bowel disease (including Crohn's disease, ulcerative colitis); rheumatoid arthritis; scleroderma; systemic lupus erythematosus; autoimmune vasculitis; myasthenia gravis; myositis; autoimmune hepatitis; antiphospholipid syndrome; Wegener's granulomatosis; Sjögren's syndrome; Guillain-Barré syndrome; or multiple sclerosis, etc.
- History of organ transplantation or allogeneic stem cell transplantation.
- Patients with laboratory test values not meeting the relevant criteria within 7 days prior to enrollment.
- Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.
- Patients with severe, uncontrolled medical conditions or infections. Examples include: severe myocardial infarction, heart failure, unstable angina, or unstable arrhythmia within the past 6 months; respiratory failure and chronic obstructive pulmonary disease; active hepatitis B virus (HBV) infection (HBV-DNA ≥2000 U/mL); hepatitis C virus (HCV) infection; active tuberculosis infection, etc.
- Concurrent use of other investigational drugs or participation in other clinical trials.
- Patients who refuse or are unable to sign the informed consent form for participation in the trial.
- Patients with known allergies or contraindications to the investigational anti-tumor drug or any of its excipients.
- Patients deemed by the investigator to be unsuitable for participation in the study and unlikely to comply with the study procedures, restrictions, and requirements.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100021
Yuan Tang, MD, PhD, +86-15011304945, tangyuan82@126.com
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen
Shenzhen, Guangdong
Yangmei Zhou, MD, PHD, +86-0755-66618168-51251, szchiec@163.com
About this study
Official title: A Multicenter, Phase III, Randomized Controlled Clinical Trial of Sintilimab Versus Mitomycin in Combination With Capecitabine and Intensity-Modulated Radiotherapy in the Treatment of Limited-stage Anal Squamous Cell Carcinoma
This is a prospective, multicenter, open-label, phase III randomized controlled clinical trial designed to evaluate the efficacy and safety of replacing the traditional chemotherapeutic drug mitomycin with the PD-1 inhibitor sintilimab in definitive chemoradiotherapy for limited-stage anal squamous cell carcinoma. The study plans to enroll 350 previously untreated patients with limited-stage anal squamous cell carcinoma and randomize them in a 1:1 ratio into two groups: the control group will receive the current standard treatment, namely intensity-modulated radiotherapy (IMRT) concurrent with capecitabine and mitomycin; the experimental group will receive an innovative "immunotherapy replacement" regimen, namely IMRT of the same technique concurrent with capecitabine and sintilimab. The study adopts a dual primary endpoint design, aiming to verify that the experimental group is non-inferior to the control group in the clinical complete response rate at 6 months after radiotherapy, and is significantly superior to the control group in the incidence of grade 3 or higher treatment-related acute toxicities.
- Being tested
- Intensity-Modulated Radiotherapy (IMRT), Capecitabine, Sintilimab, Mitomycin (MMC)
- Keywords
- anal squamous cell carcinoma, intensity-modulated radiotherapy, immune checkpoint inhibitors, immunotherapy
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-Modulated Radiotherapy (IMRT)Radiation
Intensity-modulated radiotherapy (IMRT) will be administered:
- Primary tumor: 1.8 Gy per fraction, 28-30 fractions, total dose 50.4-54 Gy;
- Metastatic lymph nodes: 1.68-1.8 Gy per fraction, 30 fractions, total dose 50.4-54 Gy;
- Elective nodal regions: 1.5 Gy per fraction, 28-30 fractions, total dose 42-45 Gy; Treatment will be administered 5 days per week, concurrently with systemic chemotherapy (capecitabine ± mitomycin/sintilimab), in accordance with institutional standard practice for anal squamous cell carcinoma.
CapecitabineDrug
Oral capecitabine at 825 mg/m² twice daily on days of radiotherapy, concurrent with IMRT, as part of the chemoradiotherapy backbone for both study arms.
SintilimabBiological
Intravenous sintilimab at 200 mg every 3 weeks, administered concurrently with capecitabine and IMRT to the experimental arm as an immunotherapy replacement for mitomycin.
Mitomycin (MMC)Drug
Intravenous mitomycin at 10 mg/m² as a single bolus dose on day 1 of radiotherapy, administered only to the control arm as part of the standard chemoradiotherapy regimen.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: Mitomycin + Capecitabine + IMRT | Active comparator | Standard definitive chemoradiotherapy for limited-stage anal squamous cell carcinoma: Intensity-modulated radiotherapy (IMRT) concurrent with capecitabine and mitomycin. Receives: Radiation: Intensity-Modulated Radiotherapy (IMRT); Drug: Capecitabine; Drug: Mitomycin (MMC) |
| Experimental Arm: Sintilimab + Capecitabine + IMRT | Experimental | Innovative immunotherapy replacement regimen: Intensity-modulated radiotherapy (IMRT) concurrent with capecitabine and sintilimab (PD-1 inhibitor) for limited-stage anal squamous cell carcinoma. Receives: Radiation: Intensity-Modulated Radiotherapy (IMRT); Drug: Capecitabine; Biological: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Complete Response (cCR) Rate
cCR is defined as the simultaneous fulfillment of the following criteria: ① Digital rectal examination (DRE): no palpable nodule or ulcer, with only a smooth scar or fibrosis remaining; ② Anoscopy: no macroscopic evidence of residual tumor, with histopathological biopsy required for confirmation if suspicious lesions are present; ③ PET/CT: no residual tumor or new metastatic disease, or no evidence of residual tumor on contrast-enhanced CT or MRI if PET/CT is unavailable.
Measured: 6 months after radiotherapy
Grade ≥3 acute TRAEs
According to the CTCAE version 5.0 criteria, non-hematologic toxicities of grade ≥3 (including cutaneous and mucosal reactions, gastrointestinal reactions, and genitourinary reactions), hematologic toxicities (including leukopenia, neutropenia, thrombocytopenia, and anemia, excluding lymphopenia), and immune-related adverse events occurring from the start of local treatment to 90 days after the completion of treatment will be evaluated. The investigator will determine whether these events are treatment-related adverse events.
Measured: From the start of local treatment to 90 days after the completion of treatment
Secondary outcomes (10)
AEs rate
The incidence and severity of all-grade adverse events during treatment and post-treatment will be evaluated according to CTCAE version 5.0, and investigators will determine whether they are immune-related adverse events (irAEs).
Measured: 2 years after randomization
Quality of life (QoL) in cancer patients
Quality of life in cancer patients will be evaluated using the European Organisation for Treatment and Research of Cancer (EORTC) Quality of Life Questionnaires QLQ-C30. The scoring and interpretation of the QLQ-C30 scales were performed according to the EORTC guidelines. Each item is scored from 0 to 100, with higher scores indicating better functioning on the functional scales/items and more severe symptoms on the symptom scales/items.
Measured: Baseline, 3 days after completion of radiotherapy, 1 month after radiotherapy, 3 months after radiotherapy, 6 months after radiotherapy, every 3 months up to 2 years after randomization
quality of life (QoL) in anal cancer patients
Anal cancer-specific quality of life will be evaluated using the European Organisation for Treatment and Research of Cancer (EORTC) Quality of Life Questionnaires QLQ-ANL27. The scoring and interpretation of the QLQ-ANL27 scales were performed according to the EORTC guidelines.
Measured: Baseline, 3 days after completion of radiotherapy, 1 month after radiotherapy, 3 months after radiotherapy, 6 months after radiotherapy, every 3 months up to 2 years after randomization
Anal function
Anal function will be evaluated using the Wexner incontinence score. This scoring system consists of 5 items evaluating the frequency of gas incontinence, frequency of liquid incontinence, frequency of solid incontinence, frequency of wearing pads, and lifestyle alterations, with a score ranging from 0-4 for each question. The total score is calculated, with higher scores indicating poorer anal function.
Measured: Baseline, 3 days after completion of radiotherapy, 1 month after radiotherapy, 3 months after radiotherapy, 6 months after radiotherapy, every 3 months up to 2 years after randomization
PFS
Progression-free survival (PFS) is defined as the time from enrollment to the first documentation of disease recurrence or progression per RECIST 1.1 criteria, or death from any cause, whichever occurs first. For participants without any event, PFS will be censored at the last follow-up.
Measured: 2 years after randomization
CFS
Colostomy-free survival (CFS) is defined as the time from enrollment to the first occurrence of permanent colostomy (due to tumor residual/recurrence, severe treatment-related toxicity leading to loss of anal function, or disease progression/recurrence) or death from any cause, whichever occurs first. For participants without any event, CFS will be censored at the last follow-up.
Measured: 2 years after randomization
LRFS
Locoregional recurrence-free survival (LRFS) is defined as the time from enrollment to the first occurrence of locoregional disease progression (local recurrence or regional lymph node recurrence) or death from any cause, whichever occurs first. For participants without any event, LRFS will be censored at the last follow-up.
Local recurrence (LR) is defined as the reappearance of tumor in the anal canal, perianal skin, rectum, or anastomotic site. Persistent disease (tumor that never achieved clinical complete response [cCR] after chemoradiotherapy) is considered an event for statistical analysis, but assessment of residual disease within 6 months after radiotherapy completion is not recommended.
Regional lymph node recurrence is defined as the reappearance of tumor in regional lymph node drainage areas within the radiation field, including inguinal, mesorectal, presacral, internal iliac, external iliac, and obturator lymph nodes.
Measured: 2 years after randomization
DMFS
Distant metastasis-free survival (DMFS) is defined as the time from enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first. For participants without any event, DMFS will be censored at the last follow-up.
Measured: 2 years after randomization
OS
Overall survival (OS) is defined as the time from enrollment to death from any cause. For participants without any event, OS will be censored at the last follow-up.
Measured: 2 years after randomization
Rate of treatment interruption
The proportion of any unplanned radiotherapy interruptions during the scheduled radiotherapy course due to treatment-related adverse events.
Measured: 2 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start17 Mar 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Squamous Cell Carcinoma, Limited-stageStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIN JING, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jing Jin, MD, PhD, Principal investigator, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692152
- Sponsor's protocol ID
- NCC6140
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase III, Randomized Controlled Clinical Trial of Sintilimab Versus Mitomycin in Combination With Capecitabine and Intensity-Modulated Radiotherapy in the Treatment of Limited-stage Anal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07692152
- Acronym / sponsor ID
- NCC6140
- Keywords
- anal squamous cell carcinoma, intensity-modulated radiotherapy, immune checkpoint inhibitors, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 9 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 prospective, multicenter, open-label, phase III randomized controlled clinical trial designed to evaluate the efficacy and safety of replacing the traditional chemotherapeutic drug mitomycin with the PD-1 inhibitor sintilimab in definitive chemoradiotherapy for limited-stage anal squamous cell carcinoma. The study plans to enroll 350 previously untreated patients with limited-stage anal squamous cell carcinoma and randomize them in a 1:1 ratio into two groups: the control group will receive the current standard treatment, namely intensity-modulated radiotherapy (IMRT) concurrent with capecitabine and mitomycin; the experimental group will receive an innovative "immunotherapy replacement" regimen, namely IMRT of the same technique concurrent with capecitabine and sintilimab. The study adopts a dual primary endpoint design, aiming to verify that the experimental group is non-inferior to the control group in the clinical complete response rate at 6 months after radiotherapy, and is significantly superior to the control group in the incidence of grade 3 or higher treatment-related acute toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Mitomycin + Capecitabine + IMRT | Active comparator | Radiation: Intensity-Modulated Radiotherapy (IMRT), Drug: Capecitabine, Drug: Mitomycin (MMC)Standard definitive chemoradiotherapy for limited-stage anal squamous cell carcinoma: Intensity-modulated radiotherapy (IMRT) concurrent with capecitabine and mitomycin. |
| Experimental Arm: Sintilimab + Capecitabine + IMRT | Experimental | Radiation: Intensity-Modulated Radiotherapy (IMRT), Drug: Capecitabine, Biological: SintilimabInnovative immunotherapy replacement regimen: Intensity-modulated radiotherapy (IMRT) concurrent with capecitabine and sintilimab (PD-1 inhibitor) for limited-stage anal squamous cell carcinoma. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histopathologically confirmed primary anal squamous cell carcinoma, including a subset of rectal squamous cell carcinomas. Definition for inclusion of rectal squamous cell carcinomas: According to Williams' criteria (1979) and WHO classification (2019), rectal squamous cell carcinomas included in this study must meet all of the following criteria: (1) Histopathologically confirmed as pure squamous cell carcinoma, excluding adenosquamous carcinoma; (2) Digital examination/endoscopy/MRI confirmation that the tumor mass is entirely located in the rectum (above the dentate line), with no evidence of primary origin in the anal canal or upward spread. If the inferior border of the tumor is within 5-6 cm from the anal verge, and the patient is scheduled to undergo radical radiotherapy and chemotherapy, the rectal squamous cell carcinoma can be diagnosed and screened for inclusion (When the primary epicenter cannot be determined, regardless of which side the tumor mass is biased towards, the diagnosis shall be considered for screening and inclusion as anal squamous cell carcinoma); (3) Female patients must be excluded for rectal metastasis from cervical squamous cell carcinoma (baseline gynecological examination is recommended).
- Staged as cT2-T4N0M0 or cTanyN+M0 by imaging (AJCC 9th).
- No prior tumor resection surgery (other than biopsy) or chemotherapy or other anti-tumor therapy.
- Aged 18-75 years old.
- ECOG performance status of 0-1.
Key exclusion criteria (16 listed)
- Perianal squamous cell carcinoma originating from the perianal skin without invasion of the anal canal or anal sphincter. (For tumors with an ill-defined primary site, if clinical judgment indicates the main tumor mass involves the anal canal or is associated with anal sphincter invasion requiring sphincter-preserving chemoradiotherapy, the patient is eligible for inclusion.)
- Perianal Paget's disease.
- Pregnant or lactating women.
- Severe comorbidities or any medical/psychiatric condition deemed unsuitable for participation in this study.
- Patients with prior antitumor immunotherapy (e.g., anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies, etc.), with the exception of anti-HPV vaccination.
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 |
|---|---|---|
| Intensity-Modulated Radiotherapy (IMRT)Intensity-modulated radiotherapy (IMRT) will be administered: * Primary tumor: 1.8 Gy per fraction, 28-30 fractions, total dose 50.4-54 Gy; * Metastatic lymph nodes: 1.68-1.8 Gy per fraction, 30 fractions, total dose 50.4-54 Gy; * Elective nodal regions: 1.5 Gy per fraction, 28-30 fractions, total dose 42-45 Gy; Treatment will be administered 5 days per week, concurrently with systemic chemotherapy (capecitabine ± mitomycin/sintilimab), in accordance with institutional standard practice for anal squamous cell carcinoma. | Radiation | Control Arm: Mitomycin + Capecitabine + IMRT, Experimental Arm: Sintilimab + Capecitabine + IMRT |
| CapecitabineOral capecitabine at 825 mg/m² twice daily on days of radiotherapy, concurrent with IMRT, as part of the chemoradiotherapy backbone for both study arms. | Drug | Control Arm: Mitomycin + Capecitabine + IMRT, Experimental Arm: Sintilimab + Capecitabine + IMRT |
| SintilimabIntravenous sintilimab at 200 mg every 3 weeks, administered concurrently with capecitabine and IMRT to the experimental arm as an immunotherapy replacement for mitomycin. | Biological | Experimental Arm: Sintilimab + Capecitabine + IMRT |
| Mitomycin (MMC)Intravenous mitomycin at 10 mg/m² as a single bolus dose on day 1 of radiotherapy, administered only to the control arm as part of the standard chemoradiotherapy regimen. | Drug | Control Arm: Mitomycin + Capecitabine + IMRT |
Primary outcome
Clinical Complete Response (cCR) Rate
Time frame: 6 months after radiotherapy
cCR is defined as the simultaneous fulfillment of the following criteria: ① Digital rectal examination (DRE): no palpable nodule or ulcer, with only a smooth scar or fibrosis remaining; ② Anoscopy: no macroscopic evidence of residual tumor, with histopathological biopsy required for confirmation if suspicious lesions are present; ③ PET/CT: no residual tumor or new metastatic disease, or no evidence of residual tumor on contrast-enhanced CT or MRI if PET/CT is unavailable.
Grade ≥3 acute TRAEs
Time frame: From the start of local treatment to 90 days after the completion of treatment
According to the CTCAE version 5.0 criteria, non-hematologic toxicities of grade ≥3 (including cutaneous and mucosal reactions, gastrointestinal reactions, and genitourinary reactions), hematologic toxicities (including leukopenia, neutropenia, thrombocytopenia, and anemia, excluding lymphopenia), and immune-related adverse events occurring from the start of local treatment to 90 days after the completion of treatment will be evaluated. The investigator will determine whether these events are treatment-related adverse events.
10 secondary outcomes
AEs rate
Time frame: 2 years after randomization
Quality of life (QoL) in cancer patients
Time frame: Baseline, 3 days after completion of radiotherapy, 1 month after radiotherapy, 3 months after radiotherapy, 6 months after radiotherapy, every 3 months up to 2 years after randomization
quality of life (QoL) in anal cancer patients
Time frame: Baseline, 3 days after completion of radiotherapy, 1 month after radiotherapy, 3 months after radiotherapy, 6 months after radiotherapy, every 3 months up to 2 years after randomization
Anal function
Time frame: Baseline, 3 days after completion of radiotherapy, 1 month after radiotherapy, 3 months after radiotherapy, 6 months after radiotherapy, every 3 months up to 2 years after randomization
PFS
Time frame: 2 years after randomization
CFS
Time frame: 2 years after randomization
LRFS
Time frame: 2 years after randomization
DMFS
Time frame: 2 years after randomization
OS
Time frame: 2 years after randomization
Rate of treatment interruption
Time frame: 2 years after randomization
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 9 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Jing Jin, MD, PhD principal investigator
Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensity-Modulated Radiotherapy (IMRT), Capecitabine and Sintilimab in people with Anal Squamous Cell Carcinoma, Limited-stage, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 11 inclusion and 16 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 9 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 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 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 Yangmei Zhou, MD, PhD (+86 0755-66618168-51251, szchiec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Complete Response (cCR) Rate (time frame: 6 months after radiotherapy). 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 9 Jul 2026.