Can a Triple-Drug induction boost anal cancer remission?
NCT ID NCT07800000
First seen Sep 02, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether adding the investigational drug becotatug vedotin to pucotenlimab and capecitabine before standard chemoradiotherapy can improve outcomes for people with locally advanced squamous cell carcinoma of the anal canal. Participants first receive two cycles of the drug combination, then proceed to chemoradiotherapy plus immunotherapy if their disease does not progress. The study measures how many patients achieve a complete response at 40 weeks and tracks safety. It enrolls about 34 adults aged 18 to 75 with EGFR-positive disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- becotatug vedotin combined with pucotenlimab and capecitabine, followed by chemoradiotherapy plus immunotherapy
- What this could lead to
- If successful, this approach could improve complete response rates and offer a new full-course treatment option for locally advanced anal cancer.
- What could go wrong
- This is a small, early-phase exploratory trial. The combination may cause significant side effects, and results may not confirm broader benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged between 18 and 75 years, male or female; 2. Voluntarily signed the informed consent form and is willing to comply with protocol-specified requirements; 3. Histologically confirmed locally advanced anal squamous cell carcinoma of cT2-4N0-1M0 stage; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 5. EGFR immunohistochemistry (IHC) score ≥1+ as assessed by pathological laboratory; 6. At least one measurable target lesion according to RECIST version 1.1; 7. Laboratory parameters meeting all of the following criteria: (1) Bone marrow function: haemoglobin (Hb) ≥90 g/L; white blood cell count (WBC) ≥3.0×10⁹/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; (2)Renal function: serum creatinine (Cr) ≤1.5 × upper limit of normal (ULN), and endogenous creatinine clearance (Ccr) ≥55 mL/min; (3)Liver function: total bilirubin ≤1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; (4)Coagulation function: international normalized ratio of prothrombin time (PT-INR) ≤1.5 × ULN, and activated partial thromboplastin time (aPTT) within the normal reference range; 8. Left-ventricular ejection fraction (LVEF) ≥50%; 9. Female subjects of child-bearing potential agree to use contraception during the study and for 6 months after study completion; have a negative serum or urine pregnancy test within 7 days prior to enrolment, and are not breastfeeding. Male subjects agree to use contraception during the study and for 6 months after study completion; 10. No participation in other investigational-drug clinical trials within 4 weeks before enrolment; 11. The subject is capable of understanding and willing to adhere to protocol-required visits, treatment, laboratory tests and other study procedures. Exclusion Criteria: 1. Diagnosis of another malignancy within the past 5 years (excluding concurrent CIN2+ or cervical cancer; in-situ carcinomas and basal-cell carcinomas outside the pelvic region are permitted). 2. Pre-existing peripheral neuropathy ≥ Grade 2 (per CTCAE Version 5.0). 3. Patients planning to undergo or having previously received organ or bone-marrow transplantation. 4. Any major surgery within 4 weeks prior to the first study treatment (diagnostic biopsy excluded). 5. Any anti-tumour therapy administered within 4 weeks prior to the first study treatment, including radiotherapy, chemotherapy, targeted therapy, immunotherapy, biologic therapy, etc. 6. Presence of uncontrolled clinical cardiac signs or diseases. 7. Active infection or fever (excluding confirmed tumour-related fever). 8. History or evidence of interstitial lung disease or active non-infectious pneumonitis. 9. Patients with other medical conditions rendering them ineligible for enrolment, such as immunodeficiency, active pulmonary tuberculosis, hepatitis B (enrolment is allowed if treated HBV-DNA \<500 IU/mL with normal liver function; HPV-positive subjects are eligible; subjects with immunodeficiency with undetectable viral load and normal CD4-T-cell count may be enrolled), positive hepatitis-C virus testing, uncorrectable electrolyte disturbances, uncontrolled pericardial effusion, pleural effusion, and ascites. 10. Known hypersensitivity to any study drug specified in this protocol. 11. Pregnant or breastfeeding women. 12. Subjects deemed ineligible for enrolment at the investigator's discretion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Hospital
Chengdu, Sichuan, 610041, China
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