Squamous Cell Carcinoma of the Anal CanalPhase 2NCT07800000
Becotatug Vedotin Plus Pucotenlimab and Capecitabine Followed by Concurrent Chemoradiotherapy-Immunotherapy for Locally Advanced Squamous Cell Carcinoma of the Anal Canal
A Phase 2 study testing Induction therapy, Concurrent chemoradiotherapy-immunotherapy and Maintenance therapy in people with Squamous Cell Carcinoma of the Anal Canal, run by Wang Xin at 1 site in China.
Trial summary
This is a single-arm, exploratory clinical study intended to enroll patients with EGFR-positive Locally Advanced Squamous Cell Carcinoma of the Anal Canal (T2-4N0-1M0). Patients will first receive 2 cycles of induction therapy consisting of Becotatug Vedotin combined with Pucotenlimab and Capecitabine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Cell Carcinoma of the Anal Canal
- What is being tested?
- Induction therapy, Concurrent chemoradiotherapy-immunotherapy and Maintenance therapy
- 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
- 34 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2026to 31 May 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
- Aged between 18 and 75 years, male or female;
- Voluntarily signed the informed consent form and is willing to comply with protocol-specified requirements;
- Histologically confirmed locally advanced anal squamous cell carcinoma of cT2-4N0-1M0 stage;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- EGFR immunohistochemistry (IHC) score ≥1+ as assessed by pathological laboratory;
- At least one measurable target lesion according to RECIST version 1.1;
- 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.
Who cannot join
- 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).
- Pre-existing peripheral neuropathy ≥ Grade 2 (per CTCAE Version 5.0).
- Patients planning to undergo or having previously received organ or bone-marrow transplantation.
- Any major surgery within 4 weeks prior to the first study treatment (diagnostic biopsy excluded).
- Any anti-tumour therapy administered within 4 weeks prior to the first study treatment, including radiotherapy, chemotherapy, targeted therapy, immunotherapy, biologic therapy, etc.
- Presence of uncontrolled clinical cardiac signs or diseases.
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- Active infection or fever (excluding confirmed tumour-related fever).
- History or evidence of interstitial lung disease or active non-infectious pneumonitis.
- 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.
- Known hypersensitivity to any study drug specified in this protocol.
- Pregnant or breastfeeding women.
- Subjects deemed ineligible for enrolment at the investigator's discretion.
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
West China Hospital
Chengdu, Sichuan, 610041
Feng Wen, +86 28 85422589, 172571964@qq.com
About this study
Official title: An Open-Label, Single-Arm, Phase Ⅱ Exploratory Clinical Study of Becotatug Vedotin Combined With Pucotenlimab and Capecitabine Followed by Concurrent Chemoradiotherapy Plus Immunotherapy for Locally Advanced Squamous Cell Carcinoma of the Anal Canal
This is a single-arm, exploratory clinical study intended to enroll patients with EGFR-positive Locally Advanced Squamous Cell Carcinoma of the Anal Canal (T2-4N0-1M0). Patients will first receive 2 cycles of induction therapy consisting of Becotatug Vedotin combined with Pucotenlimab and Capecitabine. Patients without disease progression upon radiological assessment will subsequently proceed to the concurrent chemoradiotherapy-immunotherapy phase, which comprises Capecitabine plus Pucotenlimab and mitomycin-C together with definitive concurrent radiotherapy. In the subsequent maintenance phase, patients will receive Pucotenlimab for a total duration of 1 year. The study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab and Capecitabine, as well as the potential of this novel full-course treatment paradigm.
Read the detailed description
This is a single-arm, exploratory clinical study intended to enroll patients with EGFR-positive Locally Advanced Squamous Cell Carcinoma of the Anal Canal (T2-4N0-1M0). The study consists of two phases: a safety lead-in phase and an expansion phase. Six patients will be enrolled first with close monitoring for dose-limiting toxicities (DLTs). Further enrollment into the expansion phase will proceed only after safety is confirmed. The therapeutic regimen remains identical across both phases. The trial will be terminated if any DLT occurs during the safety lead-in phase. The observation period for the safety lead-in phase ends upon completion of 2 cycles of induction therapy.
After subjects provide written informed consent, eligible patients who meet the inclusion criteria following screening will receive induction therapy: Becotatug Bedotin (2.0 mg/kg intravenously on Day 1) combined with Pucotenlimab (200 mg intravenously on Day 1) and Capecitabine (1000 mg/m² orally twice daily). Treatment is administered every 3 weeks for a total of 2 cycles. All patients will undergo radiological assessment after completion of cycle 2 induction therapy. Patients without disease progression will subsequently enter the concurrent chemoradiotherapy-immunotherapy phase, receiving Capecitabine (825 mg/m² orally twice daily), Pucotenlimab (200 mg intravenously on Day 1), and mitomycin-C (10 mg/m² intravenously on Day 1 and Day 28), administered concurrently with definitive radiotherapy. In the maintenance phase, patients receive Pucotenlimab (200 mg) for a total duration of 1 year.
The primary endpoints of this study are the 40-week complete response (CR) rate and safety. Secondary endpoints include the objective response rate (ORR) and disease control rate (DCR) of induction therapy, event-free survival (EFS), overall survival (OS). Tumour response assessment will be performed according to RECIST version 1.1.
- Being tested
- Induction therapy, Concurrent chemoradiotherapy-immunotherapy, Maintenance therapy
- Keywords
- Becotatug Bedotin, Pucotenlimab, Induction therapy, Chemoradiotherapy-immunotherapy, Maintenance therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction therapyDrug
Patients receive becotatug vedotin (2.0 mg/kg intravenously on Day 1) plus pucotenlimab (200 mg intravenously on Day 1) and capecitabine (1000 mg/m² orally twice daily) every 3 weeks for 2 consecutive cycles.
Concurrent chemoradiotherapy-immunotherapyRadiation
Following induction therapy, patients without disease progression receive capecitabine (825 mg/m² orally twice daily) combined with pucotenlimab (200 mg intravenously on Day 1) and mitomycin-C (10 mg/m² intravenously on Day 1 and Day 28), administered in parallel with definitive pelvic radiotherapy. Radiotherapy doses were prescribed following NCCN, ESTRO and EORTC guideline recommendations.
Maintenance therapyDrug
After completion of concurrent chemoradiotherapy-immunotherapy, patients receive pucotenlimab (200 mg intravenously) every 3 weeks for up to 1 year as maintenance treatment.
| Study group | Role | What they receive |
|---|---|---|
| Induction therapy → concurrent chemo-immunoradiotherapy → maintenance therapy | Experimental | Patients first receive two cycles of induction therapy with Becotatug Bedotin plus Pucotenlimab and Capecitabine, followed by concurrent chemoradiotherapy-immunotherapy comprising mitomycin-C, capecitabine and pucotenlimab administered in parallel with definitive radiotherapy, and conclude with 1-year maintenance therapy using single-agent pucotenlimab. Receives: Drug: Induction therapy; Radiation: Concurrent chemoradiotherapy-immunotherapy; Drug: Maintenance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Complete response (CR) rate at 40 weeks
The CR rate at 40 weeks is defined as the number of patients who have no residual or metabolically active local tumour identified by digital rectal examination, colonoscopy with pathological assessment, and MRI, plus no distant metastasis confirmed by thoracic-abdominal CT at 40 weeks, divided by the total number of patients evaluable for CR status at 40 weeks.
Measured: 40 weeks after treatment
Safety
Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0, vital signs, and clinical laboratory test results in the Safety Analysis Set
Measured: Up to 18 months
Secondary outcomes (4)
Objective Response Rate (ORR)
The ORR is defined as the proportion of subjects achieving a complete response or partial response after completion of 2 cycles of induction therapy and prior to the initiation of concurrent chemoradiotherapy-immunotherapy.
Measured: At the end of Cycle 2 (each cycle is 21 days)
Disease Control Rate (DCR)
The DCR is defined as the proportion of subjects achieving a complete response, partial response, or stable disease upon completion of induction therapy.
Measured: At the end of Cycle 2 (each cycle is 21 days)
Event-free survival (EFS)
The EFS is defined as the time from the first study-drug administration to the earliest occurrence of disease progression, recurrence, initiation of new therapy, or death.
Measured: From the first study-drug administration up to 3 years after the end of treatment.
Overall Survival（OS）
The OS is defined as the time from the first study-drug administration to death from any cause.
Measured: From the first study-drug administration up to 3 years after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion19 Sep 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Anal CanalStudies of the same condition, open and under way.
- 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Xin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Xin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800000
- Sponsor's protocol ID
- BRIDGE
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase Ⅱ Exploratory Clinical Study of Becotatug Vedotin Combined With Pucotenlimab and Capecitabine Followed by Concurrent Chemoradiotherapy Plus Immunotherapy for Locally Advanced Squamous Cell Carcinoma of the Anal Canal
- ClinicalTrials.gov ID
- NCT07800000
- Acronym / sponsor ID
- BRIDGE
- Keywords
- Becotatug Bedotin, Pucotenlimab, Induction therapy, Chemoradiotherapy-immunotherapy, Maintenance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Wang XinUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 19 Sep 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 2 Sep 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 single-arm, exploratory clinical study intended to enroll patients with EGFR-positive Locally Advanced Squamous Cell Carcinoma of the Anal Canal (T2-4N0-1M0). Patients will first receive 2 cycles of induction therapy consisting of Becotatug Vedotin combined with Pucotenlimab and Capecitabine. Patients without disease progression upon radiological assessment will subsequently proceed to the concurrent chemoradiotherapy-immunotherapy phase, which comprises Capecitabine plus Pucotenlimab and mitomycin-C together with definitive concurrent radiotherapy. In the subsequent maintenance phase, patients will receive Pucotenlimab for a total duration of 1 year. The study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab and Capecitabine, as well as the potential of this novel full-course treatment paradigm.
Detailed description
This is a single-arm, exploratory clinical study intended to enroll patients with EGFR-positive Locally Advanced Squamous Cell Carcinoma of the Anal Canal (T2-4N0-1M0). The study consists of two phases: a safety lead-in phase and an expansion phase. Six patients will be enrolled first with close monitoring for dose-limiting toxicities (DLTs). Further enrollment into the expansion phase will proceed only after safety is confirmed. The therapeutic regimen remains identical across both phases. The trial will be terminated if any DLT occurs during the safety lead-in phase. The observation period for the safety lead-in phase ends upon completion of 2 cycles of induction therapy.
After subjects provide written informed consent, eligible patients who meet the inclusion criteria following screening will receive induction therapy: Becotatug Bedotin (2.0 mg/kg intravenously on Day 1) combined with Pucotenlimab (200 mg intravenously on Day 1) and Capecitabine (1000 mg/m² orally twice daily). Treatment is administered every 3 weeks for a total of 2 cycles. All patients will undergo radiological assessment after completion of cycle 2 induction therapy. Patients without disease progression will subsequently enter the concurrent chemoradiotherapy-immunotherapy phase, receiving Capecitabine (825 mg/m² orally twice daily), Pucotenlimab (200 mg intravenously on Day 1), and mitomycin-C (10 mg/m² intravenously on Day 1 and Day 28), administered concurrently with definitive radiotherapy. In the maintenance phase, patients receive Pucotenlimab (200 mg) for a total duration of 1 year.
The primary endpoints of this study are the 40-week complete response (CR) rate and safety. Secondary endpoints include the objective response rate (ORR) and disease control rate (DCR) of induction therapy, event-free survival (EFS), overall survival (OS). Tumour response assessment will be performed according to RECIST version 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction therapy → concurrent chemo-immunoradiotherapy → maintenance therapy | Experimental | Drug: Induction therapy, Radiation: Concurrent chemoradiotherapy-immunotherapy, Drug: Maintenance therapyPatients first receive two cycles of induction therapy with Becotatug Bedotin plus Pucotenlimab and Capecitabine, followed by concurrent chemoradiotherapy-immunotherapy comprising mitomycin-C, capecitabine and pucotenlimab administered in parallel with definitive radiotherapy, and conclude with 1-year maintenance therapy using single-agent pucotenlimab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 18 and 75 years, male or female;
- Voluntarily signed the informed consent form and is willing to comply with protocol-specified requirements;
- Histologically confirmed locally advanced anal squamous cell carcinoma of cT2-4N0-1M0 stage;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- EGFR immunohistochemistry (IHC) score ≥1+ as assessed by pathological laboratory;
Key exclusion criteria (12 listed)
- 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).
- Pre-existing peripheral neuropathy ≥ Grade 2 (per CTCAE Version 5.0).
- Patients planning to undergo or having previously received organ or bone-marrow transplantation.
- Any major surgery within 4 weeks prior to the first study treatment (diagnostic biopsy excluded).
- Any anti-tumour therapy administered within 4 weeks prior to the first study treatment, including radiotherapy, chemotherapy, targeted therapy, immunotherapy, biologic therapy, etc.
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 |
|---|---|---|
| Induction therapyPatients receive becotatug vedotin (2.0 mg/kg intravenously on Day 1) plus pucotenlimab (200 mg intravenously on Day 1) and capecitabine (1000 mg/m² orally twice daily) every 3 weeks for 2 consecutive cycles. | Drug | Induction therapy → concurrent chemo-immunoradiotherapy → maintenance therapy |
| Concurrent chemoradiotherapy-immunotherapyFollowing induction therapy, patients without disease progression receive capecitabine (825 mg/m² orally twice daily) combined with pucotenlimab (200 mg intravenously on Day 1) and mitomycin-C (10 mg/m² intravenously on Day 1 and Day 28), administered in parallel with definitive pelvic radiotherapy. Radiotherapy doses were prescribed following NCCN, ESTRO and EORTC guideline recommendations. | Radiation | Induction therapy → concurrent chemo-immunoradiotherapy → maintenance therapy |
| Maintenance therapyAfter completion of concurrent chemoradiotherapy-immunotherapy, patients receive pucotenlimab (200 mg intravenously) every 3 weeks for up to 1 year as maintenance treatment. | Drug | Induction therapy → concurrent chemo-immunoradiotherapy → maintenance therapy |
Primary outcome
The Complete response (CR) rate at 40 weeks
Time frame: 40 weeks after treatment
The CR rate at 40 weeks is defined as the number of patients who have no residual or metabolically active local tumour identified by digital rectal examination, colonoscopy with pathological assessment, and MRI, plus no distant metastasis confirmed by thoracic-abdominal CT at 40 weeks, divided by the total number of patients evaluable for CR status at 40 weeks.
Safety
Time frame: Up to 18 months
Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0, vital signs, and clinical laboratory test results in the Safety Analysis Set
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Disease Control Rate (DCR)
Time frame: At the end of Cycle 2 (each cycle is 21 days)
Event-free survival (EFS)
Time frame: From the first study-drug administration up to 3 years after the end of treatment.
Overall Survival（OS）
Time frame: From the first study-drug administration up to 3 years after the end of treatment.
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 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 2 study testing Induction therapy, Concurrent chemoradiotherapy-immunotherapy and Maintenance therapy in people with Squamous Cell Carcinoma of the Anal Canal, run by Wang Xin 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 8 inclusion and 12 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 8 Sep 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 Xin Wang (+86 28 85423609, wangxin213@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Complete response (CR) rate at 40 weeks (time frame: 40 weeks after treatment). 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 8 Sep 2026.