A Phase 2 interventional study of PD-1 Inhibitor + Chemotherapy in Anal Squamous Cell Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
Squamous cell carcinoma (SCC) of the anus is a rare malignancy. For localized anal squamous cell carcinoma , definitive chemoradiotherapy is the standard treatment. Patients who do not achieve complete response （CR）or experience recurrence require radical surgery with permanent colostomy.
In previous studies of anal squamous cell carcinoma （ASCC）, although favorable response rates were achieved after concurrent chemoradiotherapy, high rates of local recurrence and distant metastasis were also observed in patients with locally advanced disease, which adversely affect patient survival.
Clinical studies have demonstrated that single-agent PD-1/PD-L1 inhibitors, including nivolumab and pembrolizumab, show promising efficacy in advanced anal squamous cell carcinoma. Given the high recurrence rate associated with current concurrent chemoradiotherapy regimens and the characteristics of the immune microenvironment in anal cancer, the combination of immunotherapy with concurrent chemoradiotherapy is expected to improve therapeutic outcomes.
Therefore, we designed this prospective, multicenter, phase II clinical study to investigate the efficacy and safety of concurrent chemoradiotherapy combined with immune checkpoint inhibitors in anal cancer. This study aims to enhance the therapeutic effect for patients with locally advanced, recurrent, or metastatic anal squamous cell carcinoma and reduce adverse events in patients with high-risk factors after local excision or in early-stage disease.
The primary endpoints are local tumor control rate, overall survival, and radiation-related toxicity. The results will provide evidence for subsequent randomized controlled trials.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's planned enrollment of 241 is above the median of 66 across 211 interventional studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
This study consists of four cohorts. Inclusion and exclusion criteria comprise general inclusion criteria, cohort-specific inclusion criteria, general exclusion criteria, and cohort-specific exclusion criteria.
General Inclusion Criteria Age 18-75 years, male or female; confirmed squamous cell carcinoma of the anal canal or perianal region; performance status 0-1 and ≥ 3 months; Adequate organ function:(1) ≥ 1.5 ×10⁹/L; count ≥ 100 ×10⁹/L; ≥ 9 g/dL; serum albumin ≥ 3 g/dL;(2) Thyroid-stimulating hormone (TSH) ≤ 1 × (ULN), with normal T3 and T4;(3) ≤ 1.5 × ULN; and AST ≤ 2 × ULN;(4) Serum creatinine ≤ 1.5 × ULN, ≥ 60 mL/min;(5) (INR) or prothrombin time (PT) ≤ 1.5 × ULN, unless the patient is on anticoagulation with PT within the expected therapeutic range; activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN; No severe comorbidities expected to limit survival to \< 5 years; Female subjects: negative pregnancy test (if of ) or permanently non-childbearing potential; Sexually active males and females of childbearing potential must agree to use effective during the entire study period and for 12 months after completion of study treatment; Written and dated indicating the patient has been informed of all relevant aspects of the study; No concurrent medical condition requiring mandatory hormone replacement therapy; Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Inclusion Criteria for Cohort 1 In addition to the general inclusion criteria:（1）Tumor \< 5 cm (T1-2) and negative regional lymph nodes (N-) on physical examination or contrast-enhanced pelvic MRI;(2) No prior anti-tumor therapy.
Inclusion Criteria for Cohort 2 In addition to the general inclusion criteria:(1) No residual tumor detectable on physical examination or imaging after local excision;(2) No prior anti-tumor therapy including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
Inclusion Criteria for Cohort 3 In addition to the general inclusion criteria:(1) Tumor ≥ 5 cm (T3), or invasion of adjacent organs (T4), or regional lymph node positivity (N+) in mesorectal, presacral, internal/external iliac, or inguinal lymph node regions on physical examination or contrast-enhanced pelvic MRI;(2) No prior anti-tumor therapy.
Inclusion Criteria for Cohort 4 In addition to the general inclusion criteria:(1) Initial distant (M1) (liver, lung, bone, distant lymph nodes, etc.) confirmed by chest/abdominal CT or PET-CT,or pelvic recurrence after prior treatment, with or without distant metastasis.
Exclusion Criteria:
Patients with any of the following criteria are ineligible for this study:
Pathological diagnosis of other anal tumors, such as gastrointestinal stromal tumor, lymphoma, melanoma, etc.; Prior treatment with , anti-PD-L1, or anti-CTLA-4 antibodies; Previous or concurrent , except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma; Active disease or history of autoimmune disease (including but not limited to interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); excluding: autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement therapy; type 1 diabetes mellitus on a stable dose of insulin; vitiligo; childhood asthma/allergy that resolved with no intervention required in adulthood; History of immunodeficiency, including positive test, other acquired or congenital immunodeficiency disorders, history of organ transplantation or bone marrow transplantation; History of interstitial lung disease (excluding radiation pneumonitis not requiring therapy) or non-infectious pneumonitis; Active pulmonary tuberculosis confirmed by medical history or CT scan, active tuberculosis within 1 year prior to enrollment, or inactive tuberculosis for more than 1 year without standard anti-tuberculosis treatment; Active (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or active (positive anti-HCV antibody with HCV RNA above the lower limit of detection); Severe cardiac, pulmonary, hepatic, or renal dysfunction; History of psychoactive substance abuse, alcoholism, or drug addiction; Any other conditions judged by the investigator that may compromise patient safety or study compliance, including severe medical or psychiatric disorders requiring concurrent treatment, significant laboratory abnormalities, or other social or family factors.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tumor size \<5 cm (T1-2) and negative regional lymph nodes (N-) demonstrated by physical examination or contrast-enhanced pelvic MRI. After short-course radiotherapy, 4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered.
Drug: PD-1 Inhibitor + Chemotherapy
Inclusion criteria：no residual tumor visible on physical examination or imaging after local excision.Pathology after local excision reveals high-risk factors, positive margins, or unknown margins.Following short-course radiotherapy, 4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered.Primary endpoint: Severe acute toxicity.
Drug: PD-1 Inhibitor + Chemotherapy
Eligibility Criteria:Tumor ≥5 cm (T3) demonstrated by physical examination or contrast-enhanced pelvic MRI;or invasion of adjacent organs (T4);or regional lymph node positivity (N+) in the mesorectal, presacral, internal/external iliac, or inguinal lymph node regions. Treatment:Long-course radiotherapy at 54-56 Gy,concurrent with 2 cycles of albumin-bound paclitaxel plus platinum.After completion of radiotherapy,4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered. Primary Endpoint:Complete response rate (including cCR and pCR).
Drug: PD-1 Inhibitor + Chemotherapy
Eligibility Criteria:Initial distant metastasis (M1) in the liver, lung, bone, distant lymph nodes, or other sites confirmed by chest and abdominal CT or PET-CT;or pelvic recurrence after prior treatment, with or without distant metastasis. Treatment:Radiotherapy to recurrent or metastatic lesions, followed by chemotherapy combined with sintilimab. Primary Endpoint:12-month progression-free survival (PFS).
Drug: PD-1 Inhibitor + Chemotherapy
Drug page: Immune checkpoint inhibitors
chemotherapy and sintilimab
Also known as: radiotherapy
Complete response rate
the primary endpoint of cohort 3 is CR rate including cCR and pCR
Time frame: 1 month after the surgery or the decision of Watch and wait
Severe acute toxicity.
The primary endpoint for Cohort 1 (early anal squamous cell carcinoma) and Cohort 2 (post-local excision anal squamous cell carcinoma) is the rate of severe adverse events.
Time frame: from the start of radiotherapy to 3 months after the start of radiotherapy
12-month progression-free survival (PFS).
The primary endpoint for Cohort 4 (recurrent or metastetic anal squamous cell carcinoma) is 12-month progression-free survival (PFS).
Time frame: The proportion of patients who were alive and progression-free from the start of initial treatment up to 12 months.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Immune checkpoint inhibitors